All Available FDA-GCP Emails

Date
 
Title
06/12/2012"Compassionate Use" Protocols
05/10/2002"Conditional" Approval by IRB
10/25/2012"GENERAL" Investigator Site ICF
06/15/2012"Ideal" Resources for a Clinical Research Site
01/14/2005"Lost to Follow Up" Guidance
02/24/2005"mouse" signatures
02/09/2013"Relevant" Communications (E6) vs. complete records (812.140)
02/16/2011"Usual Care" Risks in Research Consent Forms
02/23/2003(no subject)
11/19/2013.gov Language on Consent Forms
03/19/20141 Continuing Review Question
08/06/20131 question
09/19/20111. Deviation - How to Call Properly, 2. NtF Proper Documentation
04/17/20092 Form FDA 1572s for 1 PI Doing Research at 2 Locations
06/25/20022 questions
07/09/20152 Questions
10/21/20132 questions for you
04/24/20122 Questions from [Redacted]
02/08/20122 Questions on Reporting Serious or Continuing Noncompliance to the FDA
06/16/20112 Research Questions
08/04/20103 General GCP Questions
02/22/20103 Questions
07/29/20133 Questions
12/15/20143rd Party Vendor Question
05/11/20045 GCP questions - Comments on question 8
05/04/20045 GCP questions - Response to Question #5
04/03/20135-lipoxygenase Inhibitor, MK-0633
11/05/200410 26 04 GCP Question regarding lab information on the Form FDA 1572
10/04/200612CFR Part 11, 11.100.c
10/30/200221 CFR 11
06/22/200521 CFR 11
12/12/200621 CFR 11
02/19/201021 CFR 11 and the IRB
05/07/201521 CFR 50, 56 vs 45 CFR 46
08/11/201521 CFR 50.25(c)
07/23/200821 CFR 54 Prior to 2299
05/28/200921 CFR 56 Docket FDA-2004-N-0117 Final Rule
09/30/201521 CFR 56.103 Question
06/03/200821 CFR 56.107 56.115 and Part 11 Questions
02/21/201321 CFR 56.108(b) Decision Tree
08/18/201521 CFR 56.109(c)
03/16/201121 CFR 312.23(a)(6)(iii)(b) Compliance Question
01/06/200521 CFR 312.50 Responsibility of Sponsor
02/25/201321 CFR 312.52 Question
10/02/201121 CFR 312.52-CRO
04/05/200521 CFR 312.62
11/19/200921 CFR 312.62 and 45 CFR 164.530 (j) (1) (2)
01/13/201021 CFR 812 Question
09/30/200821 CFR 812.150 (b)5
05/21/200421 CFR Part 11
07/02/200921 CFR Part 11
04/19/200521 CFR Part 11 (electronic records)
05/13/201121 CFR Part 11 Compliance
02/13/201221 CFR Part 11 Compliance and Study Financial Tracking and Management Systems
03/24/201021 CFR Part 11 Compliance Inquiry
07/07/200621 CFR Part 11 Regarding Clinical Data Management System
07/15/201221 CFR Part 11 Requirements - Apply to non-US sites under a US IND?
07/23/201121 CFR Part 50 for In Vitro Diagnostics
04/27/200421 CFR Question
05/24/200421 CFR question
06/19/200721 CFR vs 45 CFR
04/14/200821 CRF Part 11
03/27/201221 CRF Part 11
07/20/201521 Part 11 Audits
05/10/200221 Parts 50, 56 and 312 "Good Clinical Practices"
05/20/200221CFR11 Validation
05/21/201428 Day Mortality
10/14/200430 Day Period Between Studies
12/29/201030 Day Waiting Period between Clinical Trials
05/12/200845 CFR 46.116
10/24/201150.23 And Studies with Armed Forces
11/12/200950.24 Draft Guidance
02/23/201050.24 guidance
01/17/201350.25 (c) and the Short Form
02/19/201350.25 c - ClinicalTrials.gov Language
12/09/201550.25 C language Revisions
10/15/201350.25 C Pediatric Study
12/02/201350.25 C Question Addendum or Screening Consents
10/28/200956-110(c) - Expedited Review
03/12/2013312.120 guidance question
12/03/2010483 Form
01/05/2010483 Location
07/16/2002483 Release
05/09/2008483 Response Time
04/08/2009483s Issued to Foreign Clinical Investigators
09/01/2010483s Public or Private
09/13/2004505(i) and 520(g)
09/05/2014510(k) Approved Products - Need for clinicaltrials.gov Statement in Consent Form
08/17/2011639 Question regarding Investigator Delegation
08/30/2011748 1571 Questions
09/15/2011925 Question about the Financial Disclosure
09/30/20041488 Referral
09/30/20041488 Referral by [Redacted]
06/21/20121571 - 1572 Question
11/11/20101571 and CRO question
08/29/20121571 and Transfer of Obligations
09/06/20121571 and Transfer of Obligations
06/28/20111571 Inquiry
12/14/20091571-Block11-Question1
07/30/20021572
03/20/20031572
06/13/20031572
07/24/20031572
11/24/20031572
05/04/20041572
08/16/20041572
10/07/20041572
11/09/20051572
01/30/20061572
08/16/20061572
11/07/20061572
12/13/20061572
12/13/20071572
07/02/20091572
09/11/20091572
03/01/20101572
04/29/20101572
06/21/20101572
07/23/20101572
04/04/20121572
05/31/20121572
09/27/20121572
10/16/20141572
10/01/20041572 - Box 6
06/12/20131572 - Boxes Left Blank
02/07/20121572 - Certified Language Translators/Interpreters
05/04/20041572 -Global
06/23/20101572 - Research Labs
06/23/20101572 - Research Labs
11/26/20121572 - Section 4 - Lab Certification Question
10/15/20041572 - Section one
10/20/20041572 - Section One
07/26/20121572 2/12
08/24/20101572 and/or IOR
10/15/20091572 and 2 Principal Investigators
12/02/20101572 and an Investigator Original Signature
04/11/20081572 and Box 4pmbb041108
03/05/20081572 and Box 5
05/05/20141572 and Coordinators Who only Consent Subjects
10/10/20081572 and Financial Disclosure Forms Investigator Signatures and Dates
07/11/20051572 and Informed Consent
01/12/20111572 at a Phase I Facility
09/06/20071572 Block 3
12/02/20111572 Box #6
09/24/20141572 Box 3 and Suite #s
11/12/20141572 Box 3 Question
08/11/20151572 box 4: Single Use Lab
07/29/20091572 Box 6 Who to Include
07/20/20121572 Change in PI
07/14/20101572 clarification
06/05/20121572 Clarification
09/19/20131572 Clarity
11/17/20081572 Commitment
12/26/20061572 Completion
09/20/20111572 Completion
12/10/20141572 Completion and Signature Requirements
09/02/20031572 completion question
07/14/20081572 Database
07/25/20121572 Expiration Date
01/29/20091572 Expiration Dates
01/06/20061572 Expiration Question
01/06/20061572 Expires
11/15/20071572 for Companion Study
10/05/20071572 for Expanded Access Protocol
05/09/20021572 Form
12/29/20051572 form
08/27/20091572 Form
09/23/20101572 Form
09/23/20101572 Form
11/21/20111572 Form
10/12/20121572 Form
05/13/20131572 Form (Expiration Date April 30, 2015)
04/15/20101572 Form-Local lab
08/04/20101572 Form-Question
10/22/20131572 Form - Section 4
06/19/20101572 form: Urgent
04/28/20151572 Form and ePRO -eCOA Providers
12/05/20021572 Form and Info Sheets
08/14/20091572 Form Expiration Date
05/31/20091572 Form Expiration Date is May 31, 2009 New Form
05/28/20091572 Form Expired
06/18/20151572 Form expired
04/25/20141572 Form for Non US Study Team
07/19/20111572 Form Question
05/05/20111572 Forms
03/27/20131572 Forms
03/27/20131572 Forms
04/17/20081572 Forms for Non-US Studies
10/28/20101572 for Post Marketing Studies
05/26/20101572 Guidance - When to update 1572
08/24/20101572 Guidelines
08/12/20141572 Inclusion Questions
07/16/20071572 Inclusions
01/17/20121572 Inquiry
07/28/20071572 IRB Listing
02/24/20091572 Item #7 Question
08/30/20131572 Lab Entry
05/16/20111572 Lab Question
08/22/20071572 Line 4 Question
07/30/20101572 New
09/11/20121572 observational
04/25/20131572 OMB Expiration
06/19/20071572 Per Investigator
07/16/20101572 Phase I/II
02/18/20101572 Query on Laboratory Facilities
05/17/20021572 Question
04/22/20041572 Question
05/11/20041572 Question
09/22/20041572 question
01/14/20051572 Question
06/28/20051572 Question
10/24/20051572 question
10/25/20051572 Question
07/14/20061572 Question
01/19/20101572 Question
05/24/20101572 question
10/29/20101572 Question
12/11/20121572 Question
12/13/20121572 Question
05/29/20131572 Question
06/27/20131572 Question
10/15/20131572 Question
11/12/20131572 Question
07/28/20141572 Question
12/05/20141572 Question
12/19/20141572 Question
10/27/20151572 Question
05/09/20061572 Question (2)
01/07/20131572 Question-Delay in Signing
04/16/20121572 Question - Sub-Study
08/04/20041572 question for FDA
08/04/20041572 question for FDA
04/08/20111572 Question in regards to Record Retention
01/14/20151572 Question regarding NON-US Investigators
09/05/20031572 questions
02/01/20081572 Questions
01/05/20111572 questions
07/06/20061572 Questions/Clarification
11/24/20091572 Question Third Page
07/07/20151572 Release Date Question
09/05/20061572 Required
01/13/20101572 Requirement
10/24/20031572 requirements
01/22/20141572 Requirements and Guidelines
02/18/20101572 Revision
07/15/20091572 Section 4 Lab Question
09/05/20141572 Section 4 Study Site Locations that Perform only CLIA Waived Tests
11/03/20051572 section 5
01/06/20151572 Section 6
12/07/20071572 Signatures and Non-US Sites
08/05/20041572 SMO Question
02/21/20111572 Staff on Rotation
07/21/20101572 Sub-Investigator
07/25/20081572 Sub-Investigators and Multiple PI Listing
05/13/20101572 Submission
02/23/20151572 Submission to IRB
02/09/20121572 Update
03/08/20061572 updated address
01/29/20151572 Update Question
11/02/20071572 Updates
02/16/20071572 Use Outside of USA
05/19/20091572 Version Expires 5-31-09
09/03/20151572 Versions
09/19/20131572, CV and Delegation Log
05/08/20091572- CI Legal Name Facility Address
03/12/20071572- Multiple IRBs
09/14/20071572- Satellite Sites
05/25/20071572- Who to Include
12/03/20151572/Home Health Question
04/12/20101572s
08/20/20151572s and Foreign Sites
01/26/20121572s and Investigators
10/07/20101572s for Cooperative Group Studies
10/07/20101572s for Cooperative Group Studies
10/07/20101572s for Cooperative Group Studies
03/11/20051572S For Foreign Sites
11/08/20061995 FDA/NIH Report on the Public Forum on Informed Consent for Emergency Research
10/22/20082008 Version of GCP Guidelines
02/29/20122011 Inspection Data
02/28/20132012 Inspection Data
01/21/20142013 Inspection Data
02/03/20152013 Inspection Data
03/13/20083500A for Clinical Trial Not Requiring an IND-2
08/25/20063545 3544
05/30/20075024 Guidance
12/12/20085024 rule-FamilyMember-LAR
06/10/2015? re 1572-Is a New Version being Generated
07/07/2011About CIIL
08/21/2013About Clinical Study Image (Source Data)
07/25/2013About FDA Phrase required on ICFs
07/25/2013About FDA Phrase required on ICFs
07/07/2011About GCP Inspection Fee
02/01/2012About GCP Inspection Question
02/01/2012About GCP Inspection Question
02/08/2011About GCP Training
02/14/2008About Guidelines for Clinical Trials with Anti-Infective Agents
07/22/2014About ICF Printing on 2 Sides of Page
12/18/2013About Medical Devices
03/13/2011About Single-Sided Copy ICF
04/17/2002About statistical software accepted by FDA
04/26/2010About the investigational Medicinal Product
04/26/2010About the Investigational Medicinal Product
01/08/2014About the Reference Drug for Clinical Trials in order to get FDA Approval
10/13/2010Abstinence as Way of Contraception in Clinical Trials
05/20/2008Academia and Compliance Question #2
06/07/2006Acceptance of Clinical Trial Data from [Redacted]
04/01/2003Acceptance of foreign data
06/29/2015Access Revoke to Clinical Database
04/24/2009Access to Clinical Trial Results
12/19/2008Access to Electronic Medical Charts
12/30/2008Access to Electronic Medical Charts
02/06/2006Access to Electronic Medical Records
10/23/2013Access to Non-Research Related Medical Records
10/14/2008Access to Open Clinical Trials
01/17/2012Access to Other Company Trial Specific Worksheet/Medical Record (completed/closed trial)
08/12/2009Access to Records by Sponsor
05/24/2006Access to Research Charts
03/06/2009Access to Subject Records
01/16/2012Access to the Private Practice Records of a Principal Investigator
08/01/2006Accreditation of GCP Courses
02/15/2007Accreditation Requirement for Clinical Trial Sample Analysis
06/10/2009Accrual Hold during Amendments Review
01/08/2015ACRP
11/07/2014Actions against Investigators
09/03/2011Actual Meaning of a Verse Used In 21CFR56.106 -
01/07/2012Actual Meaning of a Word Used in 21CFR56.106
02/22/2006Adaptive Trial Design
08/01/2008Adding Dietician to FDA 1572
11/28/2012Adding Identifiers to Informed Consent Documents
06/20/2008Adding Lab on 1572
09/12/2015Adding Patient Identifying Information to Consent
01/07/2004Adding Physicians to FDA 1572
02/15/2011Adding Study Coordinator as Subinvestigator on FDA Form 1572
06/20/2008Adding Subject Number to ICD
06/25/2007Adding Subject Number to ICF
08/08/2012Additional Analysis after Study Completion
08/05/2015Additional I/E Requirements - Not Specified by Protocol
02/02/2015Additional IRB Responsibilities when FDA Observes Study Procedures
04/28/2011Additional Record Retention Question
12/03/2010Address Change of Sponsor
12/19/2006Address for Acting Director of FDA Good Clinical Practice
01/18/2010Address for AE Reporting
04/28/2014Address for ORO?
07/27/2010Address on the Medical License of PI Conducting Clinical Research at that Site
06/09/2003Adequate Personnel
09/11/2009Adherence of the Independent Ethics Committees outside the USA to 21CFR56
12/24/2015Ad Hoc Narration of Procedure Demo Video by Research Staff
11/14/2011Administration of Study Agent to Participant While Hospitalized at a Non-Study Site
06/01/2009Administrative Changes to the Protocol
12/19/2011Administrative Letter
08/18/2011Adverse Drug Reaction Reporting
01/28/2015Adverse Drug Reaction Reporting to IRB for Post-Approval KAB Study
07/07/2011Adverse Event
05/25/2014Adverse Event Definition
10/25/2006Adverse Event Follow Up
11/05/2015Adverse Event Leading to Subject Drop Out During Investigation
06/18/2012Adverse Event Question
09/24/2013Adverse Event Question
01/28/2010Adverse Event Record Keeping
06/30/2004Adverse event reporting
02/21/2006Adverse Event Reporting
08/01/2008Adverse Event Reporting
08/27/2008Adverse Event Reporting
09/18/2014Adverse Event Reporting
10/17/2013Adverse Event Reporting: Intermittent Events
07/02/2009Adverse Event Reporting and Monitoring
05/17/2011Adverse Event Reporting Inquiry
08/28/2012Adverse Event Reporting Procedure for Marketed Drugs being used in IDE and non-IDE Device Trials
03/12/2009Adverse Event Reporting Question
05/05/2009Adverse Event Reporting to IRBs
02/09/2005Adverse Event Reports
09/12/2014Adverse Event Review
01/29/2004Adverse Events
04/15/2010Adverse Events
06/25/2013Adverse Events
04/20/2010Adverse Events Collection for Screening Failures
08/11/2003Adverse Events Reporting & Financial Interests of Clinical Investigators
07/09/2004Adverse Events vs. Medical History
04/07/2004Advertisements
01/28/2003Advertisement vs. information
10/20/2003Advertising
10/04/2010Advertising Flyers
01/23/2003Advertising for Clinical Trials
09/23/2011Advertising for Clinical Trials
07/23/2002advertising guidelines
02/28/2008Advertising Marketing Unapproved Products
06/02/2003Advertising question
04/17/2012Advertising Question
10/06/2011Advertising Remarks
08/10/2007Advertising Requiring IRB Approval
09/26/2002Advice
03/20/2008Advice for Handling HIV
02/06/2008Advice for Investigators
02/28/2003Advice needed
09/19/2014Advice on Sponsor Transfer of Responsibilities to a Phase I Unit
12/12/2007Advice Service Query (Ref No. 38)
06/13/2008Advisory Committees
02/22/2005AE After Screening
01/12/2013AE and SAE Collection
09/27/2006AE and SAE reporting
03/29/2012AE Assessment
09/30/2004AE criteria for study related
07/07/2015AE Data Collection When Should Both AESEV Severity Intensity and AETOXGR Standard Toxicity Grade be Collected
11/07/2007AE Grading Scales
05/15/2002AE Question
06/10/2005AE Question
08/17/2004AE Reporting
09/28/2011AE reporting
10/29/2009AE Reporting for a Device Trial
12/14/2007AE Reporting for Discontinued Patient
02/04/2013AE reporting in Device trial
05/15/2007AE Reporting Post Market Studies
11/08/2002AE Reporting Question
04/30/2003AE Reporting Question
01/21/2011AE reporting question
03/08/2010AE Reporting Question - Changes in Severity
05/13/2009AE Reporting to IRB's
11/11/2002AE Reporting Under IND
05/08/2009AE Reports- Does Indication Matter
05/04/2009AE Reports for Studies with Different Route of Admin
06/26/2006AE Reports Prior to IRB Approval
09/09/2002AE requiring medical intervention-Medwatch form use
08/28/2006AERs Database
12/04/2013AEs and Amended Protocols
07/03/2007AEs Before Randomization
08/15/2007AEs Post-Marketing
02/13/2009AEs Pregnancy Overdose
10/14/2005AEs Seen With the Control
02/09/2010After Completion or Termination of the Trial
02/09/2010After Completion or Termination of the Trial
05/04/2010After Completion or Termination of the Trial
04/06/2015After Consent Withdrawal
08/13/2010After IRB Withdrawal of Approval
04/07/2005AIP Question
11/01/2006Alarmed access
01/03/2006ALCOA
08/01/2013Alloderm
08/19/2013Allowing Someone on LEIE list to Perform Clinical Research Duties
04/10/2013ALS
05/24/2007Altering Informed Consent Forms
06/15/2009Alternate Members
05/08/2009Amended Protocol or New Protocol
07/27/2011Amendment Approval as Annual Renewal
05/04/2011Amendment Protocols for Clinical Research
06/29/2015Amendments to INDs
06/13/2007Amendment to Protocol
03/30/2010Amendment to Question re: Delegation of Authority for Clinical Study Physical Exams, ECG interpretations and Lab work interpretations
09/16/2010Ancillary Supplies Return Policy
02/13/2013ANDA - Investigational Product (IP) Retention
03/06/2006ANDA submission guidance
02/27/2003And more
02/27/2003And more
05/03/2010Animal Data in Informed Consent Forms
09/28/2007Annual IRB Renewals
08/08/2014Annual IRB Review Timeline Requirements for International Sites
04/27/2012Annual Report of GCP Clinical Investigator Inspections
10/07/2011Annual Reports according to CFR 312.33 - Filing at the Study Sites Necessary?
09/22/2008Annual Review of FDA Regulated Research
04/24/2007Annual Update 1572
01/31/2014Anonymized GCP Inspection Reports/Findings
04/20/2004Another Possible Source
06/14/2004Another Question
01/21/2010Another Question
06/25/2012Another Question
07/02/2012Another question
11/18/2013Another Question for You
10/29/2004Another quick question
05/24/2010Another Set of Questions
02/12/2013Antimigraine Guidance for Clinical Trial Design
02/21/2008Any Prohibitions
04/05/2006Appeals IRB
03/05/2008Applicability of 21 CFR 56.109(c)(1)
12/16/2014Applicability of 45 CFR 46
08/30/2007Applicability of 312.6(a) for IND Studies Not Being Conducted in U.S. and Drug is Not Being Imported/Exported in U.S.
12/01/2011Applicability of FDA Regulations to Nutritional Science Research
06/20/2015Applicability of FDA Regulation to and ICH GCP to Public Health Intervention Studies
01/24/2012Applicability of GCP to Observational (Non-Interventional) Studies
02/28/2003Applicability of HIPAA Regulations to Manufacturers of Medical Products
05/20/2010Applicability of Part 54
06/07/2010Applicability of Part 54
11/06/2009Applicability of Trial-Related Documents to GCP
11/17/2009Applicability of Trial-Related Documents to GCP
09/20/2012Applicable Clinical Trial - Registration on ClinicalTrials Website
10/21/2008Applicable Regulations
12/30/2013Application of Part 11 to EHR
01/28/2003Application of questionnaires in clinical trials
04/12/2006Applications Supported by Foreign Research
02/04/2010Appropriate Delegation of Clinical Trial Tasks
02/04/2010Appropriate Delegation of Clinical Trial Tasks
02/04/2010Appropriate Delegation of Clinical Trial Tasks
10/24/2005Appropriateness to Authorize work under draft SOP
02/28/2011Approval of an amended Protocol
02/25/2008Approval of Group Advertisement
08/15/2007Approval of Surgical Procedures
02/12/2008Approved Drug Use by Sponsor-Investigator
11/20/2012Archival of Clinical Trial Documents
01/01/2010Archival of Soft Copy Data
01/01/2010Archival of Soft Copy Data
01/20/2011Archived Clinical Trial
03/04/2014Archived Study records
05/05/2004Archived tissue samples and informed consent
09/15/2010Archive of Safety Mailings at Site
07/23/2007Archive of Study Records
05/19/2009Archiving Clinical Research Trial Data
05/11/2004Archiving essential documents for an observational study
01/20/2010ArchivingICForms-ERecords
04/21/2010Archiving Pharmaceutical Study Information
09/22/2008Archiving Records
07/22/2009Archiving Requirements
08/24/2011Are One-page CVs Being Required
03/01/2006Are prisoners vulnerable subjects
07/14/2009Are Requests for Vaccine Trials Same as Drug Trials
10/10/2011Are Site-Specific Procedures Auditable by The FDA?
06/04/2010Are US Agents required for Foreign INDs?
09/22/2008Arranging Inspections- Both Domestic and Foreign
07/01/2003Artificial Cervical Disk.....?
11/26/2008Ask for Help
01/28/2008Asking Subjects to Discontinue Medication
11/03/2011Assent Requirements for Subjects 18 Years and Over
03/27/2013Assessment of Adverse Event Causality
06/11/2010Assessment of Labs for a Clinical Trial
04/20/2012Assigning Sub-Investigators to a Study
08/26/2011Assistance Needed
03/16/2004ASSISTANCE PLEASE
09/28/2010Assistance Please
03/21/2013Assistance Please
06/16/2011Attaining a Certificate in Good Clinical Practice and Ethics
07/30/2015Attempts to Collect Information from Discontinued Subjects
09/10/2003Attention: Ms Carolyn Hommel - 1572 completion question
07/29/2003Attention: Stan Woollen - HIPAA/Telephone Screening
03/26/2013Audit
11/08/2010Audit/Inspection of Financial Details
04/14/2014Audit in BA/BE Studies
08/07/2013Auditing
02/15/2008Auditing Electronic CRF
05/09/2008Auditing Electronic Databases
05/02/2013Auditor Contact Information
07/01/2004Audit Question
12/16/2009Audits by the Clinical Study Monitor
04/08/2011Audit Trail Attributability
07/11/2002Authorization to admin study meds
08/01/2011Authorization use File Good Clinical Practice
01/16/2004Authorized Site Signature Logs for Clinical Trials
05/16/2008Automatically Populated Database Fields
10/16/2002autonomy guidelines
08/15/2006Availability of 1572s
08/18/2006Availability of 1572s
10/21/2008Availability of Final Guidance on AE Reporting for IRBs and Investigators
11/09/2009Availability of HRML Version- 1572
01/15/2010Availability of the Notification by Sponsor to Regulatory Authorities and IRB/IEC of CIOMS / MedWatch Reports
08/04/2008Available GCP Training
06/08/2011Available GCP Training
10/23/2015Background Therapy and SOC
01/30/2007Backup Tapes
12/19/2007Bacteriophage Clinical Trials
04/15/2014Bariatric Pacemaker
05/05/2010Basic GCP Process Info
10/16/2009Basic GCP Training
11/02/2004Becoming Certified in Regulatory Affairs/clinical Trail Practice
09/06/2010BE Facilities
02/06/2008Behavior Testing Guideline and Standard for New Drug Development
12/03/2009Belize
07/05/2007Belmont Report
09/11/2003Benchmarking information for Research Funds Flow
02/05/2009The Benefits Section of IC
10/31/2007Benefits to Study Subjects
07/13/2015Best Practice for De-Identifying Data
08/15/2007BF Edits Sponsor CPGM
05/07/2002Bias
02/04/2009Bias to the Subjects
04/10/2007Billing- Study Costs
10/28/2008Billing Insurance Companies
01/14/2015BIMO
11/05/2007A BIMO/GCP question
11/05/2007A BIMOGCP Question
11/05/2007A BIMOGCP Question CRO-Sponsor Agreement
03/24/2011Bioanalytical
08/11/2009Bioequivalence
07/24/2003Bioethics
07/06/2012Biological Sample Handling in Informed Consent
05/07/2013Biomarker GCP
05/18/2015Biometrics for Start-Up Question
05/18/2015Biometrics for Start-Up Question
01/05/2009Bioresearch Monitoring Information System Publication Schedule
03/11/2005Bioresearch Monitoring Program
06/15/2011Biospecimen Storage Collection
04/19/2010Blacklist
11/08/2006Blank CRFs
03/09/2010Blanket Approval
01/16/2013BLA Submission Timeline
07/11/2013Blinded Data Analysis
04/01/2008Blinded Research Clinical Trials
09/26/2012Blinded Study Information
09/08/2008Block1-Acronyms-Inkstamps-Signatures
02/19/2008Block 3
01/22/2009Block 4-1572 Question
07/24/2007Block 4- Analytical Labs
02/13/2009Block4-GCP Compliance Question
05/29/2007Block 6
09/02/2008Block 6
10/29/2007Block 6 Inquiry
02/12/2010Block 6 of 1572
11/13/2009Block 6- 1572
01/26/2009Block7-FDA 1572 form
02/04/2010Block8-1572 - Not found In FAQs of the Guidance Document
08/26/2008Block 8- Outline of Study
12/14/2009Block 11
04/05/2007Block 14-15 1571
04/29/2008Block Voting by IRBs During Continuing Review
05/26/2009Blood Donation by Clinical Trial Participant
07/22/2004Blood Draws from Research Subjects
07/22/2004Blood Draws from Research Subjects
02/12/2008Blood Samples and HIPAA
03/24/2009Blood Volumes- Clinical Trials
03/07/2003Board Certification
05/13/2005Board composition question
05/13/2005Board composition question
09/18/2007Board Members
02/02/2007Bonuses
09/14/2006Bonuses for Nurses
04/22/2002Book of Guidelines
07/23/2014Books and Reference Materials
06/12/2015Botox Regulations
07/30/2011Botox Trials
05/14/2003Bottom line GCP requirements for database and data processing
08/10/2012Box #4 of FDA Form 1572
11/13/2007Box 1 - 1572
05/09/2006Box 1 and Box 6 of the FDA Form 1572
06/10/2009BPC- Good Clinical Practice
06/01/2009Breakfast in Fed BE Study
03/18/2015Breaking the Double Blind Study due to Fatal SAE
10/13/2015Brief Name for Clinical Trial
07/23/2012Brother
12/15/2006Budget Question
09/23/2009By Adding Unaffiliated Lab to 1572, Does PI Become Responsible for Lab's Actions?
04/15/2012Calibration Frequency of Instrument Used in Clinical Trail
11/30/2011California Bill of Rights
11/16/2011California Bill of Rights for Human Subject Experimentation
08/10/2010Call Re informed consent waivers
03/31/2009Can an IND be Necessary for the Study of a Medical Food
05/22/2006Can An Investigator Have More Than One Site?
07/24/2009Can a Patient's Local Physician Conduct Study Visits
10/22/2008Can a Research Nurse Repackage a Controlled Substance Drug
03/14/2011Cancer Biomarker Inquiry
10/28/2015Can Date Be Written By a Research Staff on PI 's Behalf or a Date Stamp can be Used
09/16/2011Can Date Be Written by a Research Staff on PI 'S Behalf or a Date Stamp Can Be Used?
08/18/2003Can FDA inspect financial disclosure information?
10/01/2003Can FDA inspect financial disclosure information?
11/10/2010Can Ionizing Radiation be Approved via Expedited Review
03/24/2008Can IRBs Require CIs to Disclose Financial Links
11/19/2009Can LAR Sign as Impartial Witness
07/11/2003Can MDs with expired licenses serve as CIs?
09/22/2008Can Monitors Have Direct Contact with Subjects
04/03/2009Can Monitors Make Entries on CRFs
06/23/2003Cannot Locate Section 5.5.12
07/30/2015Can Nurses Determine Clinical Significance of Lab Values for a Clinical Trial
08/03/2007Can RN Perform Physical Exams
02/01/2008Can Sponsor Charge Less
09/13/2007Can Sponsor Investigators Administer Content
09/08/2008Can Study Material be Used Prior to ICF
12/05/2012Can Subject Correct Consent
01/19/2012Can this Registry Study not have a Consent Form
03/19/2010Can Wards of the State be included in Clinical Investigations?
10/02/2015Can you give Us Guidance Please?
12/09/2004Can you help?
12/09/2004Can you help?
12/10/2002Capacity to Consent
12/12/2007CAP and CLIA Laboratory Certifications
03/22/2006Capturing AEs After a Subject Signs the Informed Consent, but Prior to Administration of a Pharmaceutical Product
01/18/2013Caregiver Consent
05/04/2007Caregiver Informed Consent
08/14/2015Care Outside of Research Protocol
04/09/2002case book signatures
12/08/2006Case Report Form Binder / Medical Records
05/13/2013Case Report Form Retention at the Study Site
05/23/2006Case Report Forms
02/13/2011Case Report Forms
05/03/2007Case Report Forms and Source Document Forms
04/13/2005Case Report Forms as Source
02/12/2004Case Report Forms as Source Documents
11/01/2006Case Studies for Educational Program on the Informed Consent Process
03/21/2006Causality Assessments Defined
10/01/2009Causality Question- 2
04/30/2012CBER Inspections
05/30/2002CCRC
05/31/2012CD Copies of Electronic Data Sent to Clinical Investigators at End of Study
07/20/2006CDRH's website and inspection statistics
06/04/2014CDRH Domestic and Foreign Clinical Investigator routine BIMO Inspections
10/13/2006CDRH GCP inspections
10/16/2006CDRH GCP inspections
11/08/2010CDRH New Update
02/22/2013Central Facilities on the 1572
10/15/2004Central Files
01/27/2010Central IRB Acquisitions
07/05/2005Central IRB continuing review
05/24/2007Central IRB FDA Issue
10/14/2005Central IRB Moving
01/09/2007Central IRB Moving
05/04/2009Central IRB Reference
11/12/2012Central IRBs
10/04/2002Central Lab question
03/22/2007Certificate of Analysis
04/28/2009Certificate of Analysis for Investigational Drug
05/24/2004Certificate of Confidentiality
01/18/2006Certificate of Confidentiality
04/07/2009Certificate of Confidentiality
05/26/2015Certificate of Confidentiality
10/31/2007Certificate of Translation for Foreign Site Documents in Clinical Trials Under an IND
05/10/2002Certificate program available?
05/30/2007Certificates of Analyses
10/14/2005Certificates of Confidentiality
11/07/2007Certification
07/02/2015Certification
09/14/2006Certification Exam
09/02/2005Certification of adherence to GCP
02/17/2004Certification of Clinical Trials Center
02/18/2004Certification of Clinical Trials Center
02/18/2004Certification of Clinical Trials Center
05/18/2009Certification Question
08/28/2013Certifications and Training
04/04/2007Certified Clinical Research - Certification
12/30/2001Certified copies
09/30/2004Certified copies
10/15/2007Certified Copies
04/27/2009Certified Copies
08/10/2009Certified Copies
05/17/2011Certified Copies
11/10/2015Certified Copies
03/29/2012Certified Copies of Medical Records
04/12/2004Certified copy of source documents
04/06/2004Certified Foreign Clinical Trials Sites
06/18/2014Certified Letters to Study Subjects Lost to Follow-up
10/17/2003Certified Translations
11/07/2013CFDA
04/29/2009CFR 312.30 Question
03/08/2010CFR 312.32
11/12/2004CFR 312.62 Record Retention
02/07/2012CFR Development Question
04/24/2008CFR Fed Reg IHC Guidelines
12/11/2007CFR Part 11
03/08/2004CFR Subpart D - 312.52 - Transfer of Obligations to CRO
08/11/2009CFR SubPart D 312.52 - Central Labs and Transfer of Obligation
06/08/2009cGMP for Device Studies
06/18/2002cgp implementation guidelines for cro's
05/15/2007Chain of Custody-Tissue Samples
03/23/2011Change in Address
11/01/2005Change in IRB
06/21/2005Change in Organization
08/20/2002Change in Protocol
03/01/2007Change in Site Address
05/12/2003Change of Address
04/09/2008Change of Address
05/20/2013Change of Address Question
12/20/2007Change of Address Records
05/30/2007Change of IEC for Extended Study
11/18/2009Change of Investigator
07/27/2007Change of Principal Investigator
04/05/2005Change of Sponsor
03/10/2010Change of Sponsor for IND
02/23/2012Changes in Clinical Laboratories
07/15/2009Changes in Study Coordinator On 1571
06/14/2010Changes Regarding EC approval
03/24/2009Changes to 1572 Form
12/29/2014Changes to a 1572
05/12/2008Changes to Records
06/07/2010Change to FDA 1572
11/26/2010Changing Data Collected in a Clinical Trial
06/11/2003Charges for investigational drugs
12/13/2007Charging for Investigational Drug in an Investigator-Sponsored IND Exempt Study
09/18/2006Charging for Investigational Drugs in a Phase 4 Study
02/19/2004Charging for Research Procedures
02/10/2015Charity Responsibility
07/17/2007Child Assent Question
01/13/2011Child Assent Question
01/16/2007Child Reaching Age of Majority
11/30/2007Child Resistant Package
01/28/2003Choice of Medical Monitor for clinical trials
08/12/2008Choosing an IRB Financial Disclosure and Reading Levels of ICDs
02/18/2011Chronic Back Pain
06/11/2008CI- Inspection List
10/23/2010CI Certification
10/29/2009CI Deficiencies
09/25/2009CI Financial Interests
04/04/2011CI Inspection Findings to IRB
09/28/2007CI Not Acceptable
05/29/2012CIOMS Reviewing by Investigators and IRB
01/26/2011CI Right/Ability to Review IRB Meeting Minutes
06/30/2004CI Signature on Clinical Trial Records
03/22/2006Citation of FDA web Page not found
02/22/2011CITI GCP Online Training Program
11/29/2013Citing Risks in a Registry Study
01/14/2011CITI Training
10/28/2009Claims for Therapies Chiropractic Strokes
11/18/2003Clarification
12/15/2003Clarification
03/15/2006A Clarification
08/20/2002Clarification: telephone scripts
01/08/2014Clarification about Safety Reporting requested from [Redacted] Laboratories
11/02/2012Clarification Needed
09/01/2010Clarification Needed Regarding IRB Reporting Suspension of Enrollment
08/25/2007Clarification of 21 CFR 56.109(c)(1)
11/21/2007Clarification of Definition of a Sponsor
05/02/2008Clarification of Emergency Use for Medical Devices
11/13/2012Clarification of IND Regulations at 21 CFR 312.20(b)
05/22/2012Clarification of IRB details
03/01/2011Clarification of New Safety Regs
08/24/2011Clarification of Recordkeeping
11/27/2013Clarification of Serious Adverse Event Definition
02/23/2006Clarification of Terminology
03/11/2010Clarification on 1572 Related
11/25/2002Clarification on Exculpatory Language
09/28/2006Clarification on FDA Stand on Specific Language as "Appears to be Exculpatory"
03/15/2010Clarification on Form no. 3454 3455
06/01/2009Clarification on Guidance Regarding Reporting Adverse Events
11/18/2005Clarification on IRB Expedited Review
04/02/2010Clarification on IRB non-scientific members
02/28/2003Clarification on NDA
06/01/2009Clarification on Quorum at an IRB Meeting
01/18/2011Clarification re Confidentiality
03/14/2011Clarification regarding FDA Interpretation of ICH/GCP 4.3.2 and 4.9.1
05/17/2012Clarification regarding IRB Continuing Review
10/01/2012Clarification Request
06/04/2013Clarification requested
01/08/2015Clarification Requested on Subjects DOB Data Allowed to be Collected per Local Regulations
12/08/2010Clarifications
11/11/2011Clarifications Requested regarding Monitoring Practices Adequacy per ICH GCP Rules
11/11/2011Clarifications Requested Regarding Monitoring Practices Adequacy per ICH GCP Rules
11/13/2009Clarifying 21 CFR 312.62(b) and Re-consenting for Revised ICF
07/18/2014Clarity
07/21/2010Clarity on who can be LAR and who can be Impartial Witness
03/04/2013Classification of Study Sites Based on PI IRB and Proximity
09/14/2005CLIA
08/12/2010CLIA/CAP certificates
03/28/2011CLIA and CAP Certificate Requirement for PK Tests
02/25/2008CLIA and GLPs
05/18/2006CLIA Certification
12/21/2012CLIA Section 4 and Waived Tests
12/21/2012CLIA Section 4 and Waived Tests
11/15/2006CLIA vs. CAP
01/08/2015CLIA Waived Tests FU Question
09/30/2014CLIA Waiver
04/14/2014CLIA Waiver for Research Testing?
09/26/2007CLIA Waiver Question
08/12/2014CLIA Waiver Requirement
12/01/2011Client with Data Collection Registry
06/21/2007Clinical Complaint Definition
05/29/2008Clinical Data Archiving (Archival Grade CD DVD)
12/18/2013Clinical Database AE Cut-Off Dates
12/07/2004Clinical Data Reporting Question
11/30/2006Clinical Document Archiving
12/07/2007Clinical Drug Labeling Requirements in USA
05/14/2012Clinical for Supplements
04/26/2013Clinical Hold/Temporary Termination of Clinical Trials with Medical Devices
07/02/2008Clinical Investigations
02/22/2012Clinical Investigator Inspection List
06/01/2015Clinical Investigator Inspection List
01/15/2013Clinical Investigator Inspection Search
06/28/2010Clinical Investigator Requirements
03/03/2010Clinical Investigator Requirements Question
03/03/2010Clinical Investigator Requirements Question
05/03/2011Clinical Investigators
01/24/2008Clinical Investigator Working on Competing Drugs
08/09/2002Clinical Lab certification?
08/01/2005Clinical Laboratories
09/05/2008Clinical Laboratories- What Standards Does FDA Have?
04/03/2012Clinical Laboratories and GCP/GLP
08/27/2002Clinical laboratories in FDA-regulated research
10/02/2015Clinical Laboratories Supporting Clinical Trials
04/03/2007Clinical Laboratory
08/22/2007Clinical Laboratory Analyses in Clinical Trials
09/05/2007Clinical Laboratory Analyses in Clinical Trials
04/01/2009Clinical Laboratory Inspections
07/06/2009Clinical Laboratory Regulations
03/16/2007Clinical Laboratory Standards
07/15/2015Clinical Laboratory Testing Guidance for Clinical Trials
06/22/2011Clinical Lab Record Retention Requirements for NSR Device Study Data
07/31/2009Clinically Significant Lab Values
05/02/2006Clinical Monitor
01/23/2014Clinical Participant
05/08/2002Clinical Pharmaceutical Research Activities
02/20/2002Clinical Phase I Manufacturing
11/19/2004Clinical Protocol Review
12/10/2011Clinical Question
06/29/2007Clinical Record Keeping Requirements
08/05/2008Clinical Research
01/25/2010Clinical Research
12/28/2005Clinical Research (Principal investigator)
02/11/2010Clinical Research - Documentation of Training to the Sites
09/11/2009Clinical Research- Sponsor Provided Source Documents
05/19/2005Clinical Research and Adequate Source Documentation
12/23/2009Clinical Research and Source Documents
09/30/2004Clinical Research Associate Certification
09/22/2004Clinical Research Association Information
10/04/2005Clinical Research Audit
04/28/2006Clinical Research Coordinator
10/12/2005Clinical research Coordinators
05/17/2013Clinical Research Device Trials
03/07/2011Clinical Research Drug Study
01/11/2011Clinical Research Education
01/11/2011Clinical Research Education
03/29/2002Clinical Research Guidelines
06/19/2002Clinical Research QA Course at FDA
05/12/2014Clinical Research Question
03/26/2010Clinical Research Record Retention Question
11/18/2008Clinical Research Sites
11/08/2007Clinical Research Staffing Question
05/22/2013Clinical Research Staff Training Documentation
05/24/2013Clinical Research Staff Training Documentation
02/13/2009Clinical Research Student Need Help to Find Info
10/07/2011Clinical Research Trials
12/04/2003Clinical safety question
05/26/2004Clinical samples & GLP
10/15/2012Clinical Site Data Elements Summary Listing
04/09/2009Clinical Site Moving
11/18/2011Clinical Sites
02/03/2009Clinical Sites Location
05/25/2011Clinical Sites Using Pencil Vs Pen
04/19/2006Clinical Sites with Satellite Sites
05/13/2013Clinical Site Termination
05/29/2002Clinical Site Validation and Accreditation Process
06/16/2014Clinical Site Website
05/26/2011Clinical Studies and/or Studies
04/29/2005Clinical studies in Russia
01/30/2013Clinical Studies Questions
07/02/2008Clinical Studies Record Keeping
01/28/2015Clinical Study
08/22/2008Clinical Study- Weight Loss
08/29/2013Clinical Study Data Standards
08/29/2013Clinical Study Data Standardsat
07/23/2007Clinical Study Education
05/30/2014Clinical Study Monitors Present during FDA Inspection
04/14/2006Clinical Study Monitor Training Requirements
03/20/2009Clinical Study Reports- Listing Investigators Who Did Not Enroll Subjects
07/24/2008Clinical Study Results Database
09/08/2010Clinical Study Subject Withdrawal Consequence for Specimens Obtained
12/03/2009Clinical Study with Safety Board Charter Needed
08/26/2014Clinical Supplies
09/15/2003Clinical Supply Maintenance
06/18/2002Clinical testing in [redacted]
02/24/2005Clinical Trails Diaries - CRF
11/15/2004Clinical Training
06/27/2002Clinical Trial
06/13/2003Clinical Trial
04/07/2004Clinical Trial
07/14/2006Clinical Trial
01/11/2007Clinical Trial
09/22/2008Clinical Trial
10/23/2010Clinical Trial
11/01/2010Clinical Trial
05/11/2015Clinical Trial
04/16/2013Clinical Trial, Regulatory Questions
03/22/2012Clinical Trial - GCP Requirement when Trail Site Changed within Same City
11/19/2004Clinical Trial - HIPAA
02/20/2015Clinical Trial - PI Responsibility Question
10/20/2009Clinical Trial- Subcontractor Liability
12/23/2009Clinical Trial- Subcontractor Liability
03/16/2011Clinical Trial.
06/19/2012Clinicaltrial.gov
02/28/2011Clinical Trial?
03/29/2013Clinical Trial Agreements and the eTMF
05/07/2010Clinical Trial Amendment and Investigator Amendment Guidance
10/18/2010Clinical Trial Approval
05/21/2010Clinical Trial Asked to Participate in
09/05/2007Clinical Trial Auditor
09/14/2006Clinical Trial Audit Program
01/17/2007Clinical Trial Audits
01/07/2009Clinical Trial Branding Acronyms
11/21/2007Clinical Trial Close-Out Visit
11/18/2011Clinical Trial Close Out
11/13/2006Clinical Trial Complaints
03/09/2006Clinical Trial Conduct Question
05/20/2013Clinical Trial Consent Form
05/31/2007Clinical Trial Data
04/23/2013Clinical Trial Data Archive
02/26/2013Clinical Trial Document Archival
01/18/2012Clinical Trial Documentation Question
01/04/2013Clinical Trial Document Retention
10/06/2010Clinical Trial Dosing
01/25/2012Clinical Trial Drug Regulations
03/18/2005Clinical Trial Education
06/14/2013Clinical Trial Enrollment-Enrolling Patients from Other Countries.
11/05/2008Clinical Trial for Hep C
06/04/2004Clinical Trial GCP Questions
01/29/2011Clinical Trial Info
01/29/2004Clinical Trial Information
08/09/2006Clinical trial information
02/14/2014Clinical Trial Information
09/11/2006Clinical trial information (2)
09/16/2011Clinical Trial in Puerto Rico
05/19/2012Clinical Trial Investigators
12/01/2005Clinical Trial Length
06/06/2011Clinical Trial or Patient Survey
06/12/2013Clinical Trial Participation
10/14/2003Clinical Trial patient database
05/05/2003Clinical Trial phase information
05/06/2008Clinical Trial Phases
01/14/2009Clinical Trial Practices
11/24/2009Clinical Trial Process
07/01/2004Clinical Trial Product
11/25/2008Clinical Trial Protocol - Regional Differences
11/07/2002Clinical Trial Protocols - side effects
07/18/2013Clinical Trial Query
04/04/2002clinical trial question
04/19/2005Clinical Trial Question
06/23/2010Clinical Trial Question
10/11/2012Clinical Trial Question
07/02/2014Clinical Trial Question
03/27/2015Clinical Trial Question
03/07/2013Clinical Trial Question (IRB oversight)
04/10/2002Clinical Trial Questions
04/15/2002Clinical Trial Questions
02/20/2007Clinical Trial Record Keeping
01/06/2011Clinical Trial Record Retention
03/18/2013Clinical Trial Record Storage
06/17/2005Clinical Trial Referrals
04/14/2008Clinical Trial Registration
11/19/2009Clinical Trial Registration
05/17/2013Clinical Trial Registries
01/20/2010Clinical Trial Registry
01/07/2010Clinical Trial Registry #
06/27/2005Clinical Trial Regulations
03/04/2008Clinical Trial Regulations
03/24/2011Clinical Trial Rules
05/30/2002Clinical trials
09/18/2002clinical trials
10/04/2002Clinical trials
07/25/2003Clinical Trials
09/02/2003Clinical trials
09/03/2003Clinical Trials
09/15/2003Clinical Trials
11/10/2003Clinical trials
05/13/2004Clinical Trials
05/13/2004Clinical Trials
08/20/2004Clinical trials
02/24/2005Clinical Trials
03/09/2006Clinical Trials
06/12/2006Clinical Trials
09/05/2006Clinical Trials
01/28/2008Clinical Trials
12/28/2009Clinical Trials
04/07/2010Clinical Trials
04/07/2010Clinical Trials
04/22/2010Clinical Trials
05/17/2010Clinical Trials
12/13/2011Clinical Trials
01/24/2012Clinical Trials
05/06/2012Clinical Trials
05/09/2012Clinical Trials
11/20/2012Clinical Trials
06/17/2013Clinical Trials
07/19/2013Clinical Trials
05/11/2015Clinical Trials
02/11/2010Clinical Trials (GCP) - Medical History
02/11/2010Clinical Trials (GCP) - Medical History
07/03/2007Clinical Trials- AE
10/21/2011Clinical Trials - AE Assessments
10/03/2005Clinical trials - being seen by the investigator post-study completion
09/22/2004Clinical trials - Drug Accountability Log
03/03/2005Clinical Trials - Meaning of "All Participating Investigators
10/26/2006Clinical Trials- Signed Consent Form
10/31/2006Clinical Trials- Signed Consent Form
07/05/2006Clinical Trials- Source Data
11/05/2009Clinical Trials- Sponsor Demand
09/07/2007Clinical Trials- Sub-Investigators
04/30/2013Clinical Trials - Technical Question about Patient Transfer
01/28/2009Clinical Trials - Trial Master files - Correspondence Files
05/23/2007Clinical Trials- Under the Influence of a Narcotic
09/13/2012Clinical Trials - [Redacted]
09/03/2004Clinical Trials...
09/21/2004Clinical Trials...
06/19/2007Clinicaltrials.gov
08/14/2012ClinicalTrials.gov
01/23/2013ClinicalTrials.gov
11/22/2013clinicaltrials.gov
03/27/2013Clinicaltrials.gov Compliance
01/24/2014ClinicalTrials.gov Language
01/13/2015Clinicaltrials.Gov Language
04/17/2013ClinicalTrials.gov Locations Question
08/16/2011Clinicaltrials.gov Question
09/29/2015Clinicaltrials.gov Studies Considered to be FDA Registered Trials
09/03/2014Clinical Trials.gov Text Question
06/07/2013Clinical Trials: Letter to Lost to Followup Patients
03/29/2010Clinical Trials and Electronic Health Records
01/09/2014Clinical Trials and Human Subject Protection
12/15/2014Clinical Trials and Ordering of Tests
07/13/2006Clinical Trial Screening
02/09/2015Clinical Trials Database Question - MS Excel
03/26/2010Clinical Trials Definition
08/05/2009Clinical Trials Drug Labeling
06/14/2012Clinical Trials Educational Material
07/19/2006Clinical Trials Follow-Up
05/31/2012Clinical Trials for Cosmetics
08/06/2004Clinical trials for [Redacted]
02/17/2009Clinical Trials for [Redacted} Medications Do Not Test on [Redacted]
07/18/2005Clinical Trials in Foreign Countries
07/19/2005Clinical Trials in Foreign Countries
08/23/2004Clinical Trials Information
03/24/2010Clinical Trials Informed Consent/Authorization to Use and Disclose PHI - language question
11/05/2015Clinical Trials in Preterm Infants
10/18/2007Clinical Trials in Puerto Rico
06/02/2015Clinical Trials involving Dietary Supplements
02/25/2014Clinical Trial Site
05/03/2012Clinical Trial Sites
05/31/2005Clinical Trial Site Selection
09/04/2012Clinical Trials List
10/05/2009Clinical Trials Not Regulated by FDA
01/19/2010Clinical Trials of Marketed Approved Drugs Noncompliance Clarification
10/20/2015Clinical Trials on Hold
11/27/2012Clinical Trial Source Documentation Question
08/25/2009Clinical Trial Source Document Record Release Question
05/29/2009Clinical Trials Outside of the United States
06/02/2009Clinical Trials Outside of the United States 2
06/03/2009Clinical Trials Outside of the United States 3
07/10/2009Clinical Trials Phases
02/09/2007Clinical Trials Phases for IVDs
07/09/2008Clinical Trials Process
09/16/2003Clinical Trials Question
09/16/2003Clinical Trials Question
03/19/2004Clinical Trials Question
04/20/2004Clinical Trials Question
12/09/2004Clinical Trials Question
08/07/2013Clinical Trials Question: Can Siblings Enroll in Same Trial?
09/10/2007Clinical Trials Regs
07/03/2008Clinical Trials Reporting Guidelines
05/08/2009Clinical Trials State Requirements
03/05/2008Clinical Trial Studies
05/20/2008Clinical Trial Studies
02/07/2013Clinical Trial Study Delivery of Investigational Medicinal Product to Patients Home
03/15/2006Clinical Trial Study Site Recognition Programs
05/06/2005Clinical Trial Subject Participation
08/28/2006Clinical Trials Website
07/10/2009Clinical Trials Website and CIOMs
08/30/2007Clinical Trials with Investigator Sites in Iran
07/24/2009Clinical Trials with Special Populations
10/18/2012Clinical Trial to Collect Information
02/16/2010Clinical Trial Volunteers
07/21/2006Clinical Trial Workshop in November
08/11/2006Clinical values out-of-range
12/27/2007Close of Study
04/03/2007Close Out Visit Monitor Checklist
12/02/2008Close Relatives in the IRB
06/22/2009Closure of a Study Before All Subjects Have Completed
02/15/2007Closure of CRO
01/05/2003Closure question
06/18/2002Co-Investigators
11/04/2013Co-Investigators versus Sub-Investigators
03/15/2011Co-I vs Sub-I
07/10/2014Co-PI 1572 Form
10/12/2011Co-Principal Investigators
08/03/2004COC
08/24/2004COC
08/30/2004COC with consent form
07/29/2010Code of Federal Regulations
07/05/2007Code of Federal Regulations and Good Clinical Practices
12/07/2012Code of Federal Regulations Title 21 - PART 11 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
11/25/2002A colleague has referred me to you directly
06/14/2011Collecting AEs in Device Trials
06/18/2009Collecting Twice for Clinical Study Procedures
10/05/2007Collecting Twice for Single Procedure
01/04/2014Collection and Reporting of Run-in Data
04/15/2005Collection Medical History Data for Subjects
01/23/2014Collection of CLIA Waived Certification for Urine Pregnancy Tests
07/05/2011Collection of Documents at Close-out Visits
12/07/2012Collection of Lab Director's CV and Licensure
08/06/2008Comments 1572 Guidance
10/13/2014Comments on Informed Consent Information Sheet
05/29/2014Commercial Drug that is Subject of Sponsor's IND Study Belongs to Another Company
02/06/2013Commercially Available Product vs. Investigational Drug
07/11/2002communication
02/23/2015Communication Consultation Plan Prior to IND
06/20/2003Communication documentation
05/30/2012Community Trial Question
10/20/2004Company Name Change
06/16/2009Comparison of 2 FDA Approved Products
11/20/2012Comparison of FDA and HHS regulations
10/02/2015Compassionate Devise Use
11/16/2007Compassionate Use
06/24/2015Compassionate Use - Question regarding Process
08/12/2011Compassionate Use Protocol
08/12/2011Compassionate Use Protocol
08/30/2011Compassionate Use Protocol (Expanded Access ICF Requirement)
09/02/2005Compensation Caps for CIs
02/06/2007Compensation for Study Participation
02/10/2012Compensation in Clinical Trials
03/31/2011Compensation Medication for the Patients in Placebo Controlled Group
07/11/2011Compensation to Subjects participating in a Clinical Trial
06/11/2014Competent Subject Capable of Granting Consent but Physically Unable to Sign or Make a Mark?
03/25/2008Complaint Acknowledgments
10/05/2007Completion Box 6
05/18/2010Completion of 1572
09/20/2012Completion of 1572 - Home Blood Draws
09/21/2012Completion of 1572 - Home Blood Draws
05/06/2015Completion of 1572 by foreign investigators
01/12/2012Completion of 1572...Box 8
10/31/2005Completion of clinical trial
07/09/2010Completion of CRFs
09/08/2014Completion of ICF and Individual Insurance Policy Number
09/30/2005Completion of the Form FDA 1572
10/03/2005Completion of the Form FDA 1572
12/24/2014Compliance/PHI Question for Clinical Trial
02/24/2011Complianceonline.training
03/30/2004Compliance Question
01/04/2005Compliance Question
07/01/2008Compliance Question
06/04/2013Compliance Question
02/06/2003Compliance Question - Protocol Deviations/Violations
03/14/2003Compliance Question - Protocol Deviations/Violations
07/24/2008Compliance Questions
08/20/2010Compliance Questions
04/09/2007Compliance Questions- AE and Filing of Amendments
12/23/2009Compliance Questions for Research
02/04/2003Compliance Questions for the OGCP
11/28/2012Compliance Statement
11/16/2011Compliance Verification
01/22/2015Component Analysis
08/09/2002Computer assistance in clinical trial
06/15/2006Computerized Systems
01/28/2008Computerized Systems
04/20/2005Computerized Systems Used in Clinical Trials
01/09/2006Computerized Systems Used In Clinical Trials
04/10/2006Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
08/01/2006Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
02/16/2007Computerized Systems Used In Clinical Trials (FDA 21 CFR part 11)
09/04/2002Computer Systems
08/25/2014Computer System Validation used in Sensory Studies
12/05/2012Concept of Deviation and Violation of Protocol
05/17/2010Concerning Mid-level Providers and Role in Research
03/21/2008Concomitant Medications
07/11/2007Concomittant Meds
02/21/2011Conditional or Provisional IRB Approval
12/15/2010Conditions of Approval Study Requirements
02/16/2012Conducting a Clinical Study Evaluating a Non-FDA Approved Drug Dosage
05/05/2009Conducting Clinical Trials out of Home Office of the PI
10/01/2007Conducting Device Trial
05/09/2012Conducting Remote Visits
03/21/2004Conducting Research for a Master's Thesis
03/10/2004Conducting Research for Master's Thesis
02/05/2008Confidential Disclosure Agreement
08/12/2009Confidentiality
07/19/2010Confidentiality
07/13/2012Confidentiality
10/08/2004Confirmation
03/27/2003Confirmation of Contact Information
06/25/2015Confirmation of CRF Requirements Date of Birth
08/04/2008Conflicted Chair
11/29/2004Conflict of Interest
11/29/2004Conflict of Interest
03/23/2005Conflict of Interest
03/04/2011Conflict of Interest
08/24/2011Conflict of Interest
11/28/2012Conflict of Interest
12/21/2005Conflict of Interest/FDA Guidelines?
01/10/2012Conflict of Interest?
05/10/2010Conflict of Interest and Quorum
05/10/2010Conflict of Interest and Quorum
01/14/2013Conflict of Interest Doubt
04/23/2002Conflict of Interest in Clinical Trials
04/25/2002Conflict of Interest in Clinical Trials
11/19/2013Conflict of Interest Query
11/12/2004A Conflict of Interest Question
11/15/2004Conflict of Interest Question
02/28/2005Conflict of interest question
02/28/2005Conflict of interest question
12/19/2011Conflict of Interest Question
09/03/2009Conflict Resolved- When Can Member Resume Voting
01/30/2013Conflicts of Interest and Obtaining Consent
03/01/2005Conflicts of Interest with Principal Investigators
04/10/2002Conformity to Common Rule
01/03/2008Congressional Investigator Request for IRB Records
07/15/2003Coninvestigator signature on 1572
04/08/2015Con Meds
10/14/2008Consecutive Amendments and IRB Review
07/24/2003Consent
09/16/2008Consent
06/10/2011Consent
06/22/2011Consent
08/23/2011Consent
12/11/2013Consent and FDA Form 1572
12/17/2010Consent and Re-screening
06/20/2008Consent by Telephone
11/05/2008Consent Delegation Question
03/04/2013Consent Element regarding Alternative Treatments with Risks/Benefits
08/21/2002Consent Form
05/22/2007Consent Form
11/24/2006Consent Form- Coercive Language
04/25/2002Consent form changes
06/30/2014Consent Form Completed with Incorrect Information in a Response
03/24/2009Consent Form Question
02/25/2014Consent Form Question
02/18/2010Consent Form Revision
02/15/2007Consent Form Revisions
10/24/2012Consent Forms
10/25/2012Consent Forms (2)
05/20/2008Consent Form Safety Updates- Enrollment of New Subjects
09/22/2008Consent Form Signatures Dates
02/13/2009Consent Form Translation and Back Translation
01/31/2012Consent from a LAR
06/30/2006Consenting
05/08/2013Consenting Female Partners of Male Subjects
12/14/2009Consenting Illiterate English-Speaking Subjects
10/07/2013Consenting of Patients with Physical Impairment
10/19/2010Consent Notes
10/01/2007Consent of Competent of Child
10/26/2015Consent of Non-English Speaking Subjects
03/24/2003Consent Process
11/05/2009Consent Process
12/04/2014Consent Process Documentation
10/10/2012Consent Process for Visually Impaired Research Subject
08/08/2013Consent Process when Patients Eyes Dilated
12/10/2002consent question
06/21/2010Consent Question
01/12/2012Consent Question
05/14/2008Consent Related Questionn- ICHGCP Guidelines
07/29/2010Consent Requirements
11/04/2009Consent Requirements for Registries
07/23/2007Consent Requirements for Studies Exempt from IND and IDE and Under Emergency Use
01/02/2009Consents for Sub-studies
03/26/2009Consent Signature Question
07/25/2012Consent Signatures
07/25/2012Consent Signatures
08/14/2012Consent Signatures
06/17/2009Consent Storage Requirements
01/13/2010Consultation
02/08/2010Consultation
02/21/2010Consultation
08/07/2012Consultation
03/09/2010Consultation on clinical trial
03/09/2010Consultation on Clinical Trial
04/01/2009Consulting Laboratories
03/18/2003Contact Dr David Lepay
03/30/2004Contacting Subjects Primary MD
07/10/2003Contacts at FDA
11/03/2008Container Labels
03/03/2008Continuation of Participation- Incarcerated Subjects
12/10/2002Continuing informed consent documentation
12/22/2008Continuing Review
06/23/2009Continuing Review
04/25/2008Continuing Review- Approval Period
05/29/2012Continuing Review - Enrollment
11/29/2006Continuing Review and Emergency IND
03/15/2010Continuing Review approval question
12/07/2006Continuing Review by IRBs
11/08/2007Continuing Review During Data Analysis
03/19/2004Continuing Review in Multi-National IND Research
11/01/2005Continuing Review Lapse
02/09/2009Continuing Review Question
04/29/2007Contraception During Clinical Trials
12/29/2009Contraceptive Alternatives- Informed Consent
11/06/2012Contraceptive Use in Clinical Trials
02/04/2013Contracting and GCP in a Clinical Trial.
04/11/2012Contracting an SMO
05/06/2008Contracting Sponsor Responsibilities
01/27/2014Contract Physician as Principal Investigator
02/11/2009Contracts/Agreements
10/11/2010Contract Study Coordinators
09/30/2005Contractual versus regulatory obligations
03/07/2006Control of Investigational Product
12/29/2004Convened meetings
11/22/2005Convicted Felon Question
03/16/2012Cooperative Trials and Websites for Information
03/27/2007Coordinators in Block 6
09/07/2007Copies of E-Mail Messages
11/09/2006Copies of Signed 1572s
08/28/2015Copy
04/05/2005Copy of 2-2-98 FR Notice
02/17/2009Copy of GCP
03/18/2009Copy of GCP (2)
06/26/2009Copy of GCP Guidelines
10/16/2012Copy of ICF in Patient Medical Record
02/23/2009Copy of Informed Consent Maintained by Participating Subject
12/04/2008Copy of RE Investigator Discontinuation
03/08/2013Corporate Integrity Agreements
03/19/2007Correct a Phone Number in a Protocol
09/08/2009Corrections to eCRFs
02/26/2008Corrections To Inf Cons Doc
02/24/2015Corrections to Signed ICF
07/20/2015Corrective and Preventive Actions
04/27/2005Cosmetic Products
05/04/2007Cosmetics and OTC Monograph Products
05/05/2009Cosmetics Question
11/30/2005Co Sponsorship Agreement
02/09/2013Cost of Clinical Trial
10/10/2003Couple of Issues: Your email of 10/1
09/13/2011Course of Good Practice Clinical
08/31/2009Course on Marketing a Clinical Study
01/28/2014Course Outline-GCP & HSP
09/30/2004Courses
01/07/2005COX-2 studies
06/19/2014CRA Audit Findings
09/24/2003CRA bonuses based on site recruitment rates
09/04/2003CRA certification
11/18/2011CRA Completing CRFs
11/05/2008CRA Presenting Consent
09/26/2005CRAs
05/31/2012CRC Staffing
05/10/2010CRF - Patient Access Question
07/24/2008CRF 312.61 Definition question
03/12/2010CRF and DCF
08/04/2010CRF Approval/Notification
09/16/2008CRF as a Source Document
07/05/2007CRF as Source Document
08/09/2010CRF as Source Documents
10/01/2008CRF as the Source
03/14/2007CRF Corrections
09/25/2014CRF Data with No Source Documentation
02/27/2008CRF Query
03/22/2007CRFs
09/16/2008CRFs
02/14/2011CRFs
08/03/2007CRFs- Source Docs
08/03/2007CRFs- SourceDocs-Record Keeping
11/03/2013CRFs and Clinical Investigator Signature
06/06/2008CRFs As Source Documents
09/22/2008CRFs As Source Documents
08/19/2009CRF Signature Page
09/06/2006CRF Signatures
08/08/2003CRFs in the Regulatory Binder
08/15/2004CRFs that have direct entry data with original ink copy collected and sent to sponsor
06/30/2008CRFs to be Used...Not Your Usual CRF
08/29/2002Criteria for enrolling prisoners
04/25/2014Criteria for Entering Country or Nationality Information
09/28/2005CRO
09/06/2012CRO
09/05/2003CRO's
04/29/2010CRO - Remote Monitoring Standards for CRAs?
11/15/2007CRO and Phase I Monitoring
07/18/2006CRO Audits of Clinical Trials Sites
04/03/2007CRO Changed Address
04/19/2010CRO Closure
07/25/2003CRO Programs
11/13/2013CRO Questions to FDA1572 Update and FDA Electronic Signature Certification Letter
12/15/2010CRO Responsibilities
03/01/2013CRO Responsibilities
05/29/2008CROs and IRBs
12/23/2009CRO Services Cover Monitor and Study Coordinator for the Same Project
12/08/2005CRO SOPs
07/27/2011CRO SOPs
01/01/2006Cross Border IRB Review
06/07/2010CRO Transfer of Obligations
07/08/2014Crowd Funding for Research under IND
02/24/2011CSR Appendix 16.1.4 List of Investigators
10/25/2006CSR Appendix Question - Investigator Listing
01/20/2014CT.gov Secondary Outcomes
12/28/2010CTEP's Version of FDA Form 1572
01/10/2010CTEP-Form FDA 1572
11/19/2008CTMA or MOU for an IND Clinical Trial
07/28/2011CTMS Inquiry
02/13/2006CT PET Scan
03/17/2014CTTI Informed Consent Project - Question not directly Associated with Project
04/07/2008Cultural Differences Regarding Signature on IC
07/25/2010Cumulative Clinical Investigator Inspection Lists
07/21/2006Current CFR Part 11 regulations
06/24/2014Current CVs
07/06/2009Current Draft Guidance for the Form FDA 1572 and Device Statement of Investigator
01/13/2011Current FDA-1572 Form
08/11/2002Current FDA 1572 Form
04/05/2006Current Status of Docket No. 2004N-0018
06/17/2009Current Web Edition of FDA Form 1572 Expired May 31, 2009
07/30/2009Current Web Edition of the FDA 1572
03/19/2009Curriculum Vitae Question
03/03/2008Curriculum Vitas
10/19/2015Customer Trial/Beta Test
08/07/2008CV's and 1572's
04/13/2004CV's in clinical trials
11/30/2010CVs for Offsite Co-Investigators
03/31/2011CVs for Sub-Investigators
07/10/2015CVs of the Trial Site Staff Members Listed on the Delegation Log
02/26/2008Daily Life-Minimal Risk
05/31/2005Dangerous Goods Certification
01/07/2005Data and Safety Monitoring
05/15/2015Data and Safety Monitoring
04/24/2008Database
09/23/2015Database Inquiry
08/05/2010Database Lock
10/21/2003Database that is GCP compliant
02/22/2010Database Vendor 812 Responsibilities
04/21/2008Data Clarification Forms After Closure of Trial
04/11/2005Data collection
11/27/2012Data Collection Post Study Closure in Absence of PI
04/27/2011Data Element Traceability in Clinical Trials
12/03/2015Data Entry Question
04/04/2005Data Errors in Clinical Trials
05/29/2013Data Handling for Erroneous Samples/no ICF
09/24/2010Data Management
02/05/2008Data Management - Data Clarification Form
12/23/2008Data Management Question
12/08/2005Data Management Regulations
12/19/2011Data Mgt Question
07/31/2006Data on Study Partners and Neonates- Informed Consent
08/28/2014Data Protection in Clinical Trials Enquiry
02/13/2009Data Query Responses vs Source Docs
02/20/2003Data Safety Monitoring Boards
10/31/2007Data Standardization for Clinical Trials
10/23/2007Data Standardization for Clinical Trials -Solution-1
07/18/2005Data Transcription and the 1572
10/29/2009Data Used After Patient Withdraws ICF
03/13/2012Data Verification after Closure of IRB Review
10/15/2008Date of Study Enrollment
12/09/2010Dates on Consent Forms
10/02/2009Date Stamps
11/18/2008Date Stamps-For CIs
02/23/2012Dating Clinical Trial Documents
09/11/2013Dating of Documents-Guidance
05/02/2011Day 0 for 7-day and 15-day safety reports
06/23/2006DCF Articulated
06/26/2009DDI - CFR 56.108
05/07/2009DDI - CRO Moving Location and Inspections
06/12/2009DDI Questions on Essential Documents (FDA1572 CV)
10/06/2009DDI Revised Informed Consent Inquiry
10/03/2006DEA Requirements
12/02/2002Death Reports
12/12/2013Dec 2013 Resend Question re Toth Allen Presentation
06/30/2004Decedent Rights
11/10/2005December GCP Workshop
02/20/2003Declaration of Helsinki
05/21/2003Declaration of Helsinki
03/01/2004Declaration of Helsinki
02/24/2005Declaration of Helsinki
02/22/2006Declaration of Helsinki
07/31/2006Declaration of Helsinki
12/29/2009Declaration of Helsinki
08/30/2014Declaration of Helsinki
07/17/2009Declaration of Helsinki and GCP
10/26/2012Declaration of Helsinki in US Contracts
01/10/2007Declaration of Helsinki Version
12/07/2009Deficiencies Data
01/19/2013Defining "Applicable Clinical Trial"
11/02/2004Defining 'Promotion'
04/22/2002Definition
03/19/2009Definition-Agency
01/06/2009Definition- Applicable Clinical Trial Under FDA AA
01/29/2003Definition Caucasian Subjects
02/22/2010Definition of "Adverse Event"
06/02/2012Definition of "Data"
09/06/2011Definition of "For Cause" Inspection
07/16/2013Definition of a Double-Blind Study
04/19/2004Definition of Central Laboratory
10/12/2007Definition of Clinical Director
07/20/2011Definition of Clinical Trial
04/16/2014Definition of Clinical Trials
11/15/2005Definition of Inpatient Hospitalization
11/16/2009Definition of Inpatient Hospitalization
03/19/2009Definition of Non-Compliance
08/20/2012Definition of Patient Contact
12/11/2006Definition of Satellite Site
03/06/2009Definition of Study Phases
07/03/2012Definition of Sub Investigator in FDA study
05/21/2008Definition of Substantial Evidence
03/20/2003Definitions
05/23/2008Definitions of Various Clinical Trial Dates
11/20/2007Delegation
02/03/2010Delegation Log
06/13/2012Delegation Log Corrections
04/20/2012Delegation Logs
09/04/2013Delegation Logs
08/16/2011Delegation Logs - Internal QA monitors and
06/08/2010Delegation Logs and updates
10/15/2015Delegation of Authority
03/30/2010Delegation of Authority for Clinical Study Physical Exams, ECG Interpretations and Lab Work Interpretations
06/10/2008Delegation of Authority Form
04/01/2015Delegation of Authority for Prescribing/Ordering Investigational Product
04/01/2015Delegation of Authority for Prescribing/Ordering Investigational Product
08/11/2010Delegation of Authority Log
11/29/2011Delegation of Authority Log
12/03/2014Delegation of Authority Log
05/08/2007Delegation of Authority Logs
05/25/2010Delegation of Authority Logs and Addition to the Protocol
04/28/2009Delegation of Clinical Trial Activities
07/28/2011Delegation of Duties List Question
07/13/2011Delegation of Investigator Responsibilities
06/05/2012Delegation of Medical Decisions and Patient Care to a Licensed Nurse Practitioner
09/14/2006Delegation of Responsibility
10/21/2015Delegation of Safety/Determining Severity/Causality
11/05/2010Delegation of Tasks
07/13/2012Delegation Question
06/20/2008Delegation to Staff
11/18/2008Delegation to SubI- For 6 Months
07/27/2010Demographics CRF
08/19/2014De Novo Petitions and clinicaltrials.gov
11/24/2009Dentist Licenses
06/03/2014Deodorant
09/26/2012Dermatologic Clinical Trial Information
09/27/2012Dermatologic Clinical Trial Information
09/10/2007Description of Study Cohorts in Informed Consent
09/12/2007Designation of Principal Investigators of Clinical Trials Conducted Under Sponsor-Investigator IND or IDE Applications
05/23/2013Destroyed Source Data due to Fire
06/09/2008Destroying Investigational Drugs
07/20/2011Destruction of Clinical Trial Source Documents
09/09/2008Destruction of Source Documents 2 Years Instead of 3 Years After the Study Ended
11/04/2015Destruction of Study Drug
06/17/2010Deviation or Violation
06/16/2009Deviations
10/01/2009Deviations vs. Violations
04/28/2008Deviation Versus Violation
07/19/2013Device
01/19/2007Device GCP Question Regarding Deviations
03/02/2012Device Questions
09/21/2012Device Questions
04/12/2007Device Regulations
09/25/2014Devices Exempt from IDE Regulations
10/17/2012Device Study (Statement of Investigator)
03/19/2009Device Study Question Regarding Sub-Investigators
08/12/2014Device Study Requirements
09/06/2012Device Technicians in Clinical Trials
07/31/2008Device Under IND SR NSR Determination
10/26/2010DHR requirement
10/26/2010DHR requirement
06/23/2013Diabetic Clinicals?
12/13/2011Diagnostic testing clinical trials
11/20/2013Dialysis Facility Site for a Clinical Trial
09/12/2002Diaries as Source Documents
04/01/2015Dietary Supplement Finished Product
06/06/2008Diets for Bioeq Studies
11/04/2014Difference between GCP/ICH and only ICH Guidelines
09/13/2004Difference between ICH GCP and FDA Regulations
10/29/2014Difference between IRB and IEC
04/24/2008Difference Between NIH and FDA
01/05/2011Difference between Sub Investigator and Co Investigator
08/29/2007Difference EU USFDA Clinical Research Unit
12/28/2007Differences Between GCP and GLP
08/27/2010Differences in FDA and ICH GCP
05/09/2004Differences in FDA requirement for a DSMB and DHHS requirements
04/23/2008Differences to Monitor Data from Vaccine and Pharma Studies
01/24/2013Digital Clinical Trial Documents
02/19/2010Dilemma Question
10/08/2008Direct Contact of Monitors with Subjects
03/31/2009Direct Mail Good Clinical Practice Regulatory Information
04/12/2007Dis-enrolling Patients
10/02/2007Disclosing 483s
12/10/2010Disclosure
03/30/2011Disclosure: Financial Interest and Arrangements of Clinical Investigators
06/14/2013Discontinuance of Clinical Trial Site
06/14/2013Discontinuance of Clinical Trial Site
02/27/2010Discontinuation of Clinical Research Program
10/08/2008Discontinuing Study Drug-Subject Eligibility
04/04/2008Discrepancy Between HIPAA and HHS Regulations and FDA Non-Allowance of Waiver of Consent
05/08/2014Discrepancy of Self-Report vs. Source Documents
11/07/2007Dispense vs. Administer
09/24/2010Dispensing Investigational Products
04/15/2008Dispensing of Investigational Drugs in a Clinical Trial
05/03/2010Dispensing of Study Drugs
04/30/2007Disposing of Expired Pharmaceutical Samples
08/27/2009Disposition of Clinical Study Records
03/17/2011Dissertation EMA - FDA
03/29/2011Dissertation EMA-FDA
04/04/2011Dissertation EMA-FDA
04/12/2011Dissertation EMA-FDA
03/16/2011Dissertation EMA/FDA
03/29/2010Dissolution of Research Clinic
03/26/2010Distinction between a Protocol Violation and a Protocol Deviation
02/13/2007DMC Members
09/06/2007DMCs CVs Email Records
11/14/2012Do CFR and PROs Require EC Approval
01/09/2004Do CGMPs apply to clinical trial materials?
03/09/2004Docket No. 01N-0322 - NPRM on Sponsors Informing IRBs of Any Prior IRB Reviews
11/12/2009Doctorate Approval
03/03/2011Documentation
01/24/2011Documentation about Consent
05/29/2015Documentation for Off-Site Radiology
05/08/2008Documentation Grade of Preliminary Products for an Application for Approval
05/09/2008Documentation Grade of Preliminary Products for Application for Approval
09/22/2008Documentation of a Study Subject's Prior Medical History
09/24/2010Documentation of Clinical Trial Informed Consent Discussion- Required Elements
09/12/2014Documentation of Communication between PI and Study Team
09/22/2014Documentation of Communication between PI and Study Team
08/30/2012Documentation of Eligibility Criteria
06/16/2011Documentation of Informed Consent in Subjects' Case Histories/Statement by PI of IC & Eligibility
06/16/2011Documentation of Informed Consent in Subjects' Case Histories/Statement by PI of IC Eligibility
02/05/2009Documentation of Informed Consent of the Visually Impaired
04/27/2012Documentation of Monitoring Visits/Questions about Monitoring Report Finalization
03/13/2006Documentation of Qualifications
10/24/2004Documentation of Site Communications via Telephone Contact Reports
08/30/2004Documentation of the ICF Process
07/23/2013Documentation of Training
03/26/2012Documentation of Withdrawal from Study
10/06/2009Documentation Question
02/05/2007Documentation Retention
03/03/2011Documentation Retention
08/05/2008Documentation Storage Guidelines
01/21/2011Documentation to be Provided to CI for Reference Drug - ISF
10/24/2012Document GCP Training
08/23/2011Documenting Category of Expedited Review
04/23/2008Documenting Consent in the Subject's Records
03/19/2009Documenting Informed Consent
12/13/2012Documenting Sub-Investigators on Medical Device Statement of Investigators
03/19/2008Document Retention
03/06/2012Document Retention
04/29/2011Documents received from Sites
03/19/2010Documents Signed During an Inspection
04/04/2015Documents that the FDA Inspector is Allowed to Inspect
07/14/2008Document Storage
03/10/2008Do CVs Have to be Signed?
02/03/2009Does a Form FDA 1572 Have to Be Completed When Subjects are Consented to a Trial?
08/14/2015Does an Observational Data Collection Study meet the Definition of a Clinical Investigation?
12/15/2006Does Discarding Non-Compliant Data Constitute "Compliance"?
09/12/2014Does eTMF Need to Comply with 21 CFR Part 11
03/02/2006Does FDA Have to be Named?
04/03/2013Does FDA require CVs be Dated and Signed every Two Years?
09/25/2008Does FDA Sponsor Clinical Trials
01/23/2004Does GCPP Review Books and Articles for the Public
10/02/2006Does Hospital Need to be on 1572?
12/13/2012Does ICH-GCP E6 Require IRB Review of Subject Intake Forms as "Written Information to be Provided to Subjects"
04/27/2005Does Part 54 Apply to CI Initiated Studies
05/09/2006Does Phase Affect AE Reporting?
04/25/2013Does PMA Submission Count for Final Report
04/01/2013Does PMA Submission Meet Requirement to Send Final Report within Six Months per 21 CFR 812.150 (b)(7)
08/19/2014Does this Consent Comply with FDA Disclosure Requirements?
02/10/2013Does this Guidance apply to IRBs?
02/27/2008Do GLP Regs Apply to Clin Analyses
02/06/2009Do IND-IRB Approvals Need To Be In a Particular Order
09/15/2008Do I Need FDA Approval
08/14/2008Do IRBs Need To Review Dosing Worksheets
09/03/2008Do Licenses Have to be Updated
02/14/2015Do NIH Funded Studies Observe FDA Regulations and Should they Follow ICH-GCP Guidelines
04/21/2009Door to Study Record Area
12/27/2006Dose Administration
08/22/2007Double Billing for Study Procedures
04/01/2010Double Blinding for a Trial
05/23/2006Double Data Entry
05/14/2013Double Enrollment of Participant into a Clinical Trial
12/11/2009Doubt About Patient Records
11/05/2009Doubt Regarding ICF Update
09/20/2005A Doubt Regarding ICH-GCP
12/01/2010Doubt Regarding Results of FDA Audit at Clinical Research Site
10/29/2004Doubt Regarding the Informed Consent form
12/01/2014Doubts about GCP
10/13/2010Doubts regarding Deactivation of IRB
04/10/2008Doubts Regarding Investigator's Responsibilities
05/11/2015Do We Need to Register with ClinicalTrials.gov?
05/24/2010Downgraded AE Reporting
05/24/2010Downgraded AE rReporting
01/07/2010Draft Guidance
11/17/2006Draft Guidance- Emergency Research
12/19/2012Draft Guidance Concerning Clinical Trials
09/04/2009Draft Guidance for FDA 1572
07/23/2014Draft Guidance on Updated Informed Consent
02/28/2013Draft Guidances Publications
07/18/2014Draft Informed Consent Document
10/22/2014Draft Informed Consent Guidance
10/07/2015Draft or Unused Versions of 1572s in Investigator Site File
11/29/2011Draft Questions to Send to FDA
10/27/2006Drug + Biomarker
12/17/2003Drug accountability
08/03/2007Drug Accountability
01/10/2008Drug Accountability
05/01/2008Drug Accountability
12/08/2009Drug Accountability
06/19/2013Drug Accountability
07/17/2013Drug Accountability at Clinical Sites
09/29/2008Drug Accountability Records
12/14/2009Drug Accountability Records
05/12/2008Drug Accountability Subject Withdrawal
02/03/2012Drug Administration by Research Nurses
12/15/2009Drug Approval
04/11/2003Drug Clinical Testing
07/05/2010Drug Development
03/29/2005Drug Dispensing and Dosing of Subjects
01/30/2008Drug Export Question
04/21/2010Drug Info Comment Form FDA/CDER Site
10/20/2010Drug Info Comment Form FDA/CDER Site
04/14/2011Drug Info Comment Form FDA/CDER Site
04/21/2011Drug Info Comment Form FDA/CDER Site
04/27/2011Drug Info Comment Form FDA/CDER Site
02/04/2004DrugInfo Comment Form FDA/CDER Site
02/06/2004DrugInfo Comment Form FDA/CDER Site
02/06/2004DrugInfo Comment Form FDA/CDER Site
02/11/2004DrugInfo Comment Form FDA/CDER Site
02/11/2004DrugInfo Comment Form FDA/CDER Site
02/26/2004DrugInfo Comment Form FDA/CDER Site
03/02/2004DrugInfo Comment Form FDA/CDER Site
04/21/2004DrugInfo Comment Form FDA/CDER Site
05/11/2004DrugInfo Comment Form FDA/CDER Site
05/21/2004DrugInfo Comment Form FDA/CDER Site
05/27/2004DrugInfo Comment Form FDA/CDER Site
06/25/2004DrugInfo Comment Form FDA/CDER Site
07/13/2004DrugInfo Comment Form FDA/CDER Site
08/06/2004DrugInfo Comment Form FDA/CDER Site
08/06/2004DrugInfo Comment Form FDA/CDER Site
08/06/2004DrugInfo Comment Form FDA/CDER Site
08/30/2004DrugInfo Comment Form FDA/CDER Site
08/30/2004DrugInfo Comment Form FDA/CDER Site
08/30/2004DrugInfo Comment Form FDA/CDER Site
08/30/2004DrugInfo Comment Form FDA/CDER Site
09/07/2004DrugInfo Comment Form FDA/CDER Site
09/07/2004DrugInfo Comment Form FDA/CDER Site
09/07/2004DrugInfo Comment Form FDA/CDER Site
10/05/2004DrugInfo Comment Form FDA/CDER Site
10/08/2004DrugInfo Comment Form FDA/CDER Site
10/26/2004DrugInfo Comment Form FDA/CDER Site
10/26/2004DrugInfo Comment Form FDA/CDER Site
11/01/2004DrugInfo Comment Form FDA/CDER Site
11/12/2004DrugInfo Comment Form FDA/CDER Site
11/15/2004DrugInfo Comment Form FDA/CDER Site
11/23/2004DrugInfo Comment Form FDA/CDER Site
11/30/2004DrugInfo Comment Form FDA/CDER Site
11/30/2004DrugInfo Comment Form FDA/CDER Site
12/01/2004DrugInfo Comment Form FDA/CDER Site
12/09/2004DrugInfo Comment Form FDA/CDER Site
12/10/2004DrugInfo Comment Form FDA/CDER Site
12/17/2004DrugInfo Comment Form FDA/CDER Site
01/26/2005DrugInfo Comment Form FDA/CDER Site
02/01/2005DrugInfo Comment Form FDA/CDER Site
02/03/2005DrugInfo Comment Form FDA/CDER Site
02/22/2005DrugInfo Comment Form FDA/CDER Site
02/23/2005DrugInfo Comment Form FDA/CDER Site
03/29/2005DrugInfo Comment Form FDA/CDER Site
03/29/2005DrugInfo Comment Form FDA/CDER Site
04/07/2005DrugInfo Comment Form FDA/CDER Site
04/11/2005DrugInfo Comment Form FDA/CDER Site
05/11/2005DrugInfo Comment Form FDA/CDER Site
05/18/2005DrugInfo Comment Form FDA/CDER Site
05/31/2005DrugInfo Comment Form FDA/CDER Site
05/31/2005DrugInfo Comment Form FDA/CDER Site
06/02/2005DrugInfo Comment Form FDA/CDER Site
06/20/2005DrugInfo Comment Form FDA/CDER Site
07/12/2005DrugInfo Comment Form FDA/CDER Site
07/26/2005DrugInfo Comment Form FDA/CDER Site
07/26/2005DrugInfo Comment Form FDA/CDER Site
08/09/2005DrugInfo Comment Form FDA/CDER Site
08/11/2005DrugInfo Comment Form FDA/CDER Site
09/06/2005DrugInfo Comment Form FDA/CDER Site
10/03/2005DrugInfo Comment Form FDA/CDER Site
11/10/2005DrugInfo Comment Form FDA/CDER Site
11/22/2005DrugInfo Comment Form FDA/CDER Site
12/16/2005DrugInfo Comment Form FDA/CDER Site
01/18/2006DrugInfo Comment Form FDA/CDER Site
03/07/2006DrugInfo Comment Form FDA/CDER Site
11/24/2006DrugInfo Comment Form FDA/CDER Site
06/27/2007DrugInfo Comment Form FDA/CDER Site
07/11/2007DrugInfo Comment Form FDA/CDER Site
07/24/2008DrugInfo Comment Form FDA/CDER Site
10/14/2008DrugInfo Comment Form FDA/CDER Site
10/22/2008DrugInfo Comment Form FDA/CDER Site
02/19/2010DrugInfo Comment Form FDA/CDER Site
08/03/2010DrugInfo Comment Form FDA/CDER Site
01/27/2011DrugInfo Comment Form FDA/CDER Site
04/21/2011DrugInfo Comment Form FDA/CDER Site
06/02/2011DrugInfo Comment Form FDA/CDER Site
02/21/2013DrugInfo Comment Form FDA/CDER Site
07/28/2005DrugInfo Comment Form FDA/CDER Site - Further Inquiry
10/27/2005DrugInfo Comment Form FDA/CDER Site 10/27/05
10/27/2004DrugInfo Comment Form FDA/CIDER Site
04/17/2008Drug Info Comment Form FDACDER Site
12/01/2008Drug Info Comment Form FDACDER Site
08/05/2008DrugInfo Comment Form FDACDER Site
08/12/2009Drug Information Comment Form FDA CDER Site
03/11/2010Druglnfo Comment Form FDA/CDER Site
05/01/2011Drug Name
10/06/2008Drugs for Alzheimer's
04/15/2008Drugs in the Pipeline for Infertility
08/28/2008Drug Study Design Controls
03/25/2002Drug study paper
03/25/2009Drug Testing
08/29/2011Drug Transfers
10/12/2010Drug Trial Question
02/19/2004DSMB
10/30/2007DSMB and CEC Dual Membership
02/20/2003DSMBs for industry sponsored studies
12/19/2011DSMC Temporary Suspension
12/19/2011DSMC Temporary Suspension
06/13/2012Dual Enrollment Question
04/06/2009Due Diligence
05/29/2007Due Diligence Document
07/11/2002due diligence in reviewing patients' medical history
09/13/2006Dupuytren's Contracture
06/30/2004Duration of Study Specificity
10/25/2006E-mails and Faxes
02/13/2007E-Record Use at Investigator Site
12/11/2012E-signatures and Clinical Research
05/03/2002E-trial requirements
04/02/2003E6 GCP
02/06/2007Early Intervention Program Beyond CDRH
07/22/2010EC/RA Notification of Rejected Protocol
02/20/2011EC Dissolution
06/29/2011EC Minutes Review by Sponsor CRO
06/18/2014Econsent and Email In Lieu of Print
06/03/2013ECRF as Source
04/17/2006ECs on the 1572
04/24/2011EC Submission by Sponsor CRO
06/19/2007EDC and Screening Logs
06/25/2010EDC Lab Data Question
11/15/2010EDC Privacy Rules
12/31/2007Educational Courses
07/02/2004Education Materials
12/22/2004Education requirements for IRB members
12/22/2004Education Requirements for IRB Members
11/27/2013Effective Date of Clinical Trial Agreement
02/19/2009Effect of Study Design on Minimal Risk Determination
12/12/2005Efficacy Evaluation During Clinical Trials
07/27/2007Eight Questions
08/14/2015EIR
08/14/2015EIR
04/04/2011EIRs and 483s
10/28/2014EKG
02/18/2005Electronic approvals/correspondence
08/11/2009Electronic Archiving
07/20/2013Electronic Clinical Chart vs 21 CRF Part 11
05/07/2008Electronic Communication
04/10/2002Electronic correspondence
05/09/2002Electronic Data
06/10/2011Electronic Data Capture
11/22/2011Electronic Data Capture (EDC) query
07/30/2002Electronic Data Capture-Quality of Life Scope
04/02/2007Electronic Data Capture of SAEs
01/23/2014Electronic Document Management System
02/28/2012Electronic Essential Documents
03/15/2006Electronic Files
04/16/2013Electronic Filing Question
03/29/2005Electronic Medical Record
01/09/2013Electronic Medical Records
10/28/2013Electronic Medical Records & SDV
06/15/2007Electronic Medical Records Across Many Clinics
11/02/2015Electronic Medical Records Availability
04/01/2003Electronic medical records for clinical studies
02/11/2015Electronic Medical Records Source & Certified Copies
02/11/2010Electronic Medical Record System Question
12/18/2013Electronic Print out of Medical Records and Certified Copies
10/25/2002Electronic records
06/26/2003Electronic records
06/02/2005Electronic records
07/10/2014Electronic Records; Electronic Signatures (21 CFR Part 11)
06/21/2013Electronic Records and Hard Copies
11/15/2012Electronic Records in Research
01/28/2008Electronic Records Question
07/02/2002Electronic record storage
11/21/2012Electronic Signature and Part 11 Compliance
11/17/2015Electronic Signature Certification
02/28/2006Electronic Signature on a Group of Pages
10/28/2005Electronic signatures
06/19/2006Electronic Signatures
11/20/2006Electronic Signatures
02/06/2012Electronic Signatures
12/09/2013Electronic Signatures
11/01/2012Electronic Signatures - Clinical Investigator Contracts
11/01/2012Electronic Signatures - Clinical Investigator Contracts Followup
05/19/2015Electronic Signatures and Wet Ink Signatures on Same Document
02/26/2012Electronic Signatures on Contracts, Training Forms, etc.
03/03/2014Electronic Signatures Vs No Signatures
09/13/2006Electronic Source Document
08/12/2008Electronic Source Documentation for Clinical Trials
06/02/2011Electronic Source Documentation in Clinical Investigations - Draft Guidance December, 2010
06/08/2009Electronic Source Documents Question
08/10/2009Electronic Source Documents Question
03/27/2007Electronic Source Document Use at Investigator Site
05/05/2008Electronic System Use with No Allowance to View E-Data
04/19/2005Electronic TMF
10/01/2014Electronic Training Records
08/03/2015Eligibility
08/15/2011Eligibility Checklists
04/07/2011Eligibility Documentation
12/02/2011Eligibility of Subjects that have Previously Participated in Other Trial
05/06/2011Eligible Criteria for Paid Clinical Trials
10/27/2014Email for Questions to the FDA
04/29/2013Emailing ICF
08/16/2004Emailing Index
02/05/2013Emailing Research Documents
05/17/2007Emergency Exception to Informed Consent Draft Guidance
12/11/2008Emergency Medicine Research EFIC
10/12/2007Emergency Research
02/07/2007Emergency Research - Question
04/26/2012Emergency Unblinding Question
06/25/2009Emergency Use 5 Day Report
08/07/2009Emergency Use of a Test Article
08/11/2009Emergency Use of a Test Article-2
04/19/2004Emergency Use of Investigational Drug
02/07/2012Emergent Use question
05/16/2008EMR
03/18/2014EMR
06/30/2012EMR and Clinical Trials
07/09/2010Encryption of Clinical Trial Records Vs Accessibility
08/31/2004End Date of Subjs Participation
12/04/2012End of Trial
07/29/2013Engaged in Clinical Investigation????
05/19/2008Engaged in Human Subject Study
05/27/2015Engaged in Research Question
03/09/2005English Translations in Foreign Clinical Sites
01/03/2006ENQUIRE
10/25/2013Enquiry
01/16/2014Enquiry
06/02/2015Enquiry
02/14/2011Enquiry: Correct use of FDA1572
09/22/2011Enquiry about ICF process
02/27/2013Enquiry about Storage of Human Tissue Samples and or Derived Data Files
04/27/2010Enquiry on GCP Requirements of Investigator
09/16/2010Enquiry on the Clinical Trials
06/28/2011Enrolled, Randomised or Signature of ICF-Permitted before Signed Clinical Trial Agreement
09/19/2006Enrolling Clinical Trial Staff
08/29/2014Enrolling Prisoners
05/08/2009Enrolling Prisoners in Clinical Trial
05/16/2013Enrollment
05/12/2005Enrollment Incentives
02/03/2005Enrollment in Competing Studies
02/27/2006Enrollment of Self-Family
06/02/2015Ensuring Compliance with 21 CFR Part 211.1
07/15/2015Entries to eCRFs by the Study Monitor and EMR Printed Copies Certification
03/16/2009Entry CI Questions
10/13/2010ePRO and HIPPA Questions
09/16/2011Erythropoiesis Stimulating Agents
12/27/2012Essential/Regulatory Document Filing
10/31/2011Essential Documents
07/17/2015Essential Documents
08/02/2006Essential Documents and Providers of Centralized
06/27/2003Essential Documents Question
10/21/2010Essential Documents Retention Related Queries
06/15/2011Establishing an IRB
03/05/2003Establishment of DSMB
02/01/2013Ethical Approval Enquiry
02/04/2013Ethical Approval Enquiry
10/28/2002Ethical question
09/08/2011An Ethical Question Regarding Patients Being Approached for a Clinical Trial
08/15/2007Ethics-India
08/01/2006Ethics and Clinical Trials
11/29/2012Ethics Committee Approval Letter Query
11/29/2012Ethics Committee Approval Letter Query Study Not Conducted Under an IND
10/13/2010Ethics Committee Clarification
01/18/2013Ethics Committee Quorum Approval
10/18/2013Ethics Committee Related Queries: Kindly Opine on the Same
01/31/2014Ethics Committee Related Queries: Kindly Opine on the Same
02/10/2009Ethnicity
08/13/2014eTMF Questions
08/01/2012eTMFs and Site Investigator Files--Moving Completely to Electronic Documents
11/06/2003EU Investigators and the 1572
03/27/2008EU SUSAR and FDA IND-SR
02/05/2009Evaluation Neonatal Hypoglycemia in Clinical Trial
09/20/2006Ex-US Approval
05/19/2009Exception from Informed Consent
02/07/2007Exception from Informed Consent Requirements for Emergency Research - Question
10/03/2005Exceptions
09/25/2002Exceptions to IC
01/11/2006Exception to Informed Consent (Emergency Settings) Research
04/20/2007Excl-InclCriteria in ICF
02/09/2012Exclusion from the Definition of ACT: Uncontrolled Clinical Trials
07/16/2015Exculpatory Language
02/26/2015Exculpatory Language Question
12/17/2015Exempt Category 8 (a)
10/29/2013Exemption Explained
03/03/2008Exemption From 312
08/18/2015Exempt IVD Collection Study Question
07/07/2003Exempt research
07/08/2003Exempt research
07/07/2007Exempt research
03/02/2005Exp. vs. Full Continuing IRB Review?
02/08/2008Expanded Access- Is Inf Cons Required
09/22/2010Expanded Access Protocol
11/03/2011Expanded Access Use Program
12/10/2014Expectations of PI On-Site Presence and Oversight
05/18/2011Expedited
03/31/2011Expedited Reporting to IRB Members
03/31/2011Expedited Reporting to IRB Members
04/04/2011Expedited reporting to IRB Members
12/10/2002Expedited Review
08/21/2006Expedited Review
07/09/2007Expedited Review
05/03/2010Expedited Review
12/13/2011Expedited Review
12/27/2007Expedited Review (21 CFR 56.110)
11/09/2011Expedited Review - tampons
09/25/2008Expedited Review Category 8
05/10/2010Expedited Review for Adding New Sites
02/04/2009Expedited Review Procedures and More
03/22/2005Expedited review question
04/08/2009Expedited Reviews
07/23/2002Experimental medicine
03/04/2003Expert Systems
04/07/2006Expiration Date
01/06/2006Expiration Date- 1572
03/11/2005Expiration Date for Investigational Drug
10/03/2007Expiration Dates- Consent Forms
05/04/2015Expiration Dates for GCP
08/04/2008Expiration Of Consent Form
04/01/2009Expired 1572
07/20/2010Expired 1572
01/14/2003Expired form 1572
08/04/2009Expired Form FDA 1572
06/01/2015Expired On-line 1572
06/01/2009Expiring Form 1572
09/03/2002Expiring Form FDA 1572
06/09/2010Exploratory Clinical Trials - Category A, Surveillance
07/01/2003Exports for clinical trials
10/06/2011Extended 1.5 yr Absence of PI Acceptable
03/06/2012Extent of IRB Follow Up
09/28/2015Extent of IRB Review
10/10/2003External Adverse Event Reports
06/12/2008External Adverse Events
12/07/2007External Adverse Events Reporting
03/03/2008External AE Reports
12/16/2015External Inquiry on ICH E6
03/24/2015Extra Assessments on visits as Protocol Deviation/Violation
11/20/2003F/U to my 11/5 email
05/14/2007Facilities Providing Standard of Care
05/08/2009Facts About Source Documents- Training
06/20/2003Failure to obtain Informed Consent
08/26/2011Family Members as EC Members
01/10/2011FAQ: Form FDA 1572
08/09/2010Fasting for Labs.
09/18/2009Fax Confirmations
04/27/2010Faxed Consent Forms
03/03/2013Faxed Informed Consent Documents
04/04/2003Faxing Consents
05/05/2008Faxing Source Documents
09/28/2011Fax Number Needed
01/23/2013FCPA
10/24/2003FDA
02/11/2005FDA's 1988 Monitoring Guideline
08/15/2011FDA's Guideline for Monitoring Clinical Investigations
02/17/2012FDA's Investigator Responsibilities Training
07/27/2015FDA's Office of Good Clinical Practice
08/11/2014FDA's position on 21 CFR 312.32 IND Safety Reporting - Expected/Unexpected Adverse Event
11/10/2005FDA's Position on the Helsinki Protocols for Clinic Trials
04/29/2014FDA's views on Protocol Documents Required IRB Submission
06/03/2009FDA, Auditor and Monitor to Medical Records
09/18/2013FDA-GCP 1977
12/01/2011FDA-Regulated Trial
06/07/2011FDA - sFDA - GCP Certification in Chinese Investigative Sites
09/18/2013FDA-Standard Clinical Trials
01/06/2006FDA/CDER Site
01/12/2006FDA/CDER Site
01/26/2006FDA/CDER Site
02/21/2006FDA/CDER Site
06/19/2006FDA/CDER Site
07/07/2006FDA/CDER Site
10/18/2006FDA/CDER Site
11/07/2006FDA/CDER Site
11/28/2006FDA/CDER Site
01/30/2009FDA/CDER Site
07/13/2009FDA/CDER Site
04/21/2010FDA/Clinical Studies for [Redacted]
01/25/2011FDA/EMA GCP inspections
05/14/2014FDA/GCP/IRB Question regarding Generic Recruitment Materials for Clinical Research
03/04/2003FDA/HHS Protection of Human Research Subjects
06/14/2005FDA 483 Warning Letter Questions
03/16/2012FDA 1571
08/20/2002FDA 1572
04/15/2004FDA 1572
06/15/2004FDA 1572
08/19/2005FDA 1572
10/26/2005FDA 1572
01/24/2008FDA 1572
04/11/2008FDA 1572
02/02/2010FDA 1572
02/02/2010FDA 1572
03/26/2010FDA 1572
08/11/2010FDA 1572
11/18/2010FDA 1572
11/18/2013FDA1572 & Financial Disclosure Subinvestigator/Study Nurse who Vaccinate
10/14/2014FDA 1572 - Electronic Signatures
03/05/2014FDA 1572 - Home Visits
12/12/2008FDA 1572 - Investigator Laboratory
08/11/2013FDA1572 - Query
07/09/2010FDA 1572 - Sub-Investigators
08/19/2009FDA 1572 and Financial Disclosure Doubts
11/13/2012FDA 1572 and Subinvestigator
09/15/2015FDA 1572 Block 6
03/30/2012FDA 1572 Clinical Laboratory Inclusion
01/23/2015FDA 1572 Completed by Mexican Investigators
09/19/2010FDA 1572 Completion Section #5 - IRB Details
03/13/2014FDA 1572 Continuation Page
05/28/2009FDA 1572 Due to Expire May 31, 2009
04/09/2012FDA 1572 Expiration Date
08/27/2004FDA 1572 File
01/03/2012FDA1572 for Foreign Studies
02/21/2006FDA 1572 Form
01/26/2009FDA 1572 Form
11/06/2009FDA 1572 Form
12/25/2010FDA 1572 form
04/06/2015FDA 1572 Form - Original Signed Copies
11/30/2009FDA 1572 Form- Section #3
12/27/2012FDA 1572 Form - Section # 6
04/20/2012FDA 1572 Form: Adding Study Coordinators
05/27/2012FDA 1572 Form: Local Lab Facility Listed in Section 4
02/01/2005FDA 1572 form completion
07/17/2015FDA 1572 Form Section #10
05/30/2008FDA 1572 from Non-US Investigators in Multinational Trials Under and IND
12/17/2013FDA 1572 Out of the US Countries
03/05/2008FDA 1572 Question
03/26/2009FDA 1572 Question
03/19/2010FDA 1572 question
02/17/2012FDA 1572 Question
09/14/2015FDA 1572 Question
04/16/2012FDA 1572 Question Clinic Labs
04/08/2011FDA1572 Question not covered in FAQ
07/02/2007FDA 1572 Question RE Protocol Synopsis
02/16/2012FDA 1572 Section 6 Name of Sub-investigator with Typographical Error
04/26/2012FDA1572, 2012 Version
08/19/2010FDA 1572, Expired Forms
02/17/2010FDA 1572, FDF and Responsibility Delegation Log
10/19/2009FDA 1572- Questions Regarding OMB Approval for FDA to Use the Form Until 8-31-2011
03/08/2007FDA 1572- Revised Protocol Title
10/10/2013FDA 1572- To save with already included Site Information
06/07/2014FDA 2004 Draft Guidance, "Guidance for Industry Pharmacokinetics in Pregnancy ― Study Design, Data Analysis, and Impact on Dosing and Labeling"
05/19/2005FDA Acceptance of Pre-Clinical and Clinical Data from India
09/22/2015FDA Access to CAPAs
06/20/2013FDA Access to eTMF
05/21/2014FDA Advice Requested on Impartial Witness
07/25/2012FDA Advocating Clinical Trials Ex-US to Boost Minority Enrollment
11/21/2005FDA and Foreign Clinical Trials
07/24/2009FDA and OHRP Guidance Documents
08/23/2010FDA Approval for Conducting Clinical Studies
08/12/2009FDA Approval for Medical Procedure
06/11/2008FDA Approved
06/26/2008FDA Approved Contract Packager
08/14/2009FDA Approved Sites
11/20/2014FDA Audit
08/14/2013FDA Audit and Guidelines of use of Data for MA from Emerging Regions
08/26/2010FDA Audit Certification
08/23/2013FDA Audit of Clinical Trials
07/22/2009FDA Audit Question
11/12/2009FDA Audit Question
11/13/2009FDA Audit Question-2
08/14/2008FDA Audits
10/25/2010FDA Audits
11/04/2005FDA Audits - India
09/17/2014FDA BIMO
10/14/2004FDA Certification for Clinical Research
10/08/2002FDA CFR21 part 11
02/15/2007FDA Cite Question
01/28/2015FDA Clinical Inspections List
05/18/2012FDA Clinical Investigator Training Course 2012
06/02/2010FDA Clinical Registries Information
04/19/2007FDA Clinical Research Coordinators
04/03/2008FDA Clinical Trial Requirements for Pre-Enrollment Activities
08/20/2002FDA Comments
08/29/2002FDA Comments
09/06/2002FDA Comments
10/02/2002FDA Comments
10/04/2002FDA Comments
10/21/2002FDA Comments
12/10/2002FDA Comments
12/10/2002FDA Comments
12/17/2002FDA Comments
02/12/2003FDA Comments
02/19/2003FDA Comments
02/19/2003FDA Comments
02/19/2003FDA Comments
03/04/2003FDA Comments
03/14/2003FDA Comments
05/20/2003FDA Comments
06/16/2003FDA Comments
06/19/2003FDA Comments
06/20/2003FDA Comments
06/20/2003FDA Comments
07/18/2003FDA Comments
08/04/2003FDA Comments
09/08/2003FDA comments
09/17/2003FDA Comments
10/01/2003FDA Comments
10/01/2003FDA Comments
10/02/2003FDA Comments
10/10/2003FDA Comments
10/20/2003FDA Comments
10/22/2003FDA Comments
11/13/2003FDA Comments
11/20/2003FDA Comments
11/28/2003FDA Comments
11/28/2003FDA Comments
12/01/2003FDA Comments
12/09/2003FDA Comments
12/10/2003FDA Comments
01/12/2004FDA Comments
01/13/2004FDA Comments
01/20/2004FDA Comments
02/03/2004FDA Comments
08/03/2004FDA Comments
12/30/2004FDA Comments
08/14/2012FDA Completion Requirements - Support for a CRA
07/22/2011FDA Compliance List-Jurisdiction
08/23/2010FDA Compliance Policy Guide # 7150.13
06/30/2008FDA Conditional Approval
08/27/2009FDA Confidentiality Requirements for Investigators
09/11/2013FDA Contact
01/14/2014FDA Contact Information
01/22/2012FDA Course Availability
10/12/2012FDA Debarment List
07/24/2013FDA Debarment List _ Medical Devices
04/04/2012FDA Definition/Guidance on What Is a “Sponsor” of Research
06/29/2007FDA Definitions
02/25/2011FDA Definitions pertaining to Clinical Trials
09/30/2008FDA Draft Guidance on the Form FDA 1572 - Questions
08/04/2015FDA Draft on Informed Consent
06/14/2011FDA English
08/01/2013FDA Exemption
02/12/2003FDA expectations on GCP
05/06/2010FDA Expert-Food Supplement
05/31/2012FDA Final Rule: Reporting Information Regarding Falsification of Data - Issue Date?
02/14/2012FDA Financial Disclosure Forms
12/05/2002FDA form 1572
12/09/2002FDA Form 1572
01/15/2003FDA Form 1572
11/04/2003FDA Form 1572
01/09/2004FDA Form 1572
01/18/2004FDA Form 1572
02/28/2005FDA Form 1572
04/27/2005FDA Form 1572
08/31/2005FDA Form 1572
10/11/2005FDA Form 1572
02/17/2006FDA Form 1572
03/03/2006FDA Form 1572
06/11/2009FDA Form 1572
09/22/2010FDA Form 1572
10/20/2010FDA form 1572
03/28/2011FDA FORM 1572
08/24/2011FDA Form 1572
09/13/2011FDA Form 1572
07/12/2012FDA Form 1572
03/28/2013FDA Form 1572
03/13/2003FDA Form 1572 & HIPAA
07/07/2011FDA Form 1572 - Addition of Study Coordinator as Subinvestigator
04/15/2009FDA Form 1572 - Analytical Research Centers
06/20/2012FDA Form 1572 - Questions regarding Completion
08/12/2002FDA Form 1572 - Section 3
08/13/2015FDA Form 1572 - Section 6 - Sub-Investigator Names
04/19/2004FDA FORM 1572 /Which of Several IRBs?
04/15/2005FDA Form 1572 and Foreign Clinical Trial Sites
10/04/2002FDA Form 1572 and Institutional Policies
03/15/2006FDA Form 1572 and IRB
10/27/2011FDA Form 1572 Box 5 IRB Completion
02/23/2010FDA Form 1572 Box 6-Listing of Sub-Investigators
10/04/2002FDA form 1572 expiration
06/29/2010FDA form 1572 Expiration Date
01/27/2006FDA Form 1572 expiring 01/31/2006
10/15/2010FDA Form 1572 for Specific Clinical Trials
09/28/2011FDA Form 1572 Question
02/17/2012FDA Form 1572 Question
06/05/2013FDA Form 1572 Question
09/23/2014FDA Form 1572 Question
09/13/2012FDA Form 1572 Question Print Fonts
08/04/2015FDA Form 1572 Versions
10/15/2012FDA Form 1572, Section 3 - Additional Data Sections, How to
04/11/2012FDA Form 1572--Additional Fields
11/02/2015FDA Form 1572- Continuation Page
05/05/2009FDA Form 1572- Expiration Date May 31, 2009
06/02/2011FDA Form 1572: Effective Date
05/14/2013FDA Form 1572: Infusion Nurses included as S-I
04/25/2012FDA Form 1572: New Form
12/03/2010FDA Form 1572: Subinvestigators
05/27/2011FDA Form 3455
06/27/2012FDA Form 3455 - Why is the protocol title required?
10/29/2013FDA Form 3674 Field 8 Question
06/20/2013FDA Form Competition
01/22/2003FDA FORMs 1571 and 1572 Question
08/06/2010FDA forms 1572 & 3455
01/27/2012FDA Forms 3500 and 3500A
07/28/2011FDA GCP
08/26/2010FDA GCP Lab Certifications in Medical Device Trial
06/12/2006FDA GCP Question
03/22/2010FDA GCP Question Regarding Protocol Deviation
03/22/2010FDA GCP Question Regarding Protocol Deviation
08/04/2009FDA GCP Questions
11/05/2010FDA GCP Regulations
09/04/2015FDA GCP Training Online
02/18/2005FDA GCP Training Program
10/22/2013FDA GCP vs. ICH E-6
12/25/2014FDA Good Clinical Practice Program question
07/09/2013FDA Guidance
04/06/2011FDA Guidance for Industry and Investigators Safety Reporting Requirements
11/13/2013FDA Guidance for Sponsor-Paid Clinical Trial Subject Gifts
10/18/2010FDA Guidance on 1572 - Questions 31-33
07/29/2008FDA Guidance on Adverse Event Reporting Requirements
07/06/2011FDA Guidance Question
12/03/2012FDA Guidance Sought
05/09/2013FDA Guidelines
03/17/2005FDA Guidelines and Advertising
11/25/2008FDA Guidelines and HIPPA Regulations
04/29/2008FDA Guidelines for Dosing Volunteers in Clinical Research Trials
07/06/2005FDA guidelines for subjects who drop-out of a clinical trial
04/26/2013FDA Guideline Updates
06/09/2015FDA IDE and Trial Registration Question
01/31/2011FDA Information Sheet-GCP Manual for Investigators Revised Nov 2000
03/27/2006FDA Information Sheets
03/28/2006FDA Information Sheets
02/26/2008FDA Insp Auth Under HIPAA
08/14/2013FDA Inspection in India
02/21/2007FDA Inspection of Clinical Study Sites
05/28/2015FDA Inspections
03/01/2012FDA Inspections Access to EMR
04/18/2013FDA inspections in Canada
03/01/2010FDA Inspections of Clinical Site Investigators
06/05/2015FDA Inspector Compliance Manual on NDA (New Drug Application)
05/22/2008FDA Insp Procedures
09/13/2010FDA Investigators in Civil Litigation-Redacted
02/15/2012FDA Issues Guidance on New Informed Consent Requirements
09/02/2009FDA Jurisdiction
03/02/2015FDA Lab Address Question
03/16/2006FDA Manual
10/28/2004FDA Medical Device GCP
02/09/2012FDA New Informed Consent Elements 21 CFR 50.25 (c)
12/15/2006FDA Notification of Site Closure
01/25/2004FDA Obligation
10/03/2012FDA Phase II Trial Results?
02/16/2012FDA Policy on Receiving PI CV and Licenses
01/11/2010FDA policy statement
03/18/2003FDA position on indemnification
03/18/2003FDA position on indemnification
03/04/2003FDA question
04/15/2003FDA Question
04/30/2003FDA question
05/16/2003FDA question
06/11/2003FDA question
07/16/2003FDA question
07/22/2003FDA question
08/15/2003FDA question
08/22/2003FDA question
10/01/2003FDA question
10/06/2003FDA question
10/17/2003FDA question
02/12/2004FDA Question
03/08/2004FDA Question
03/24/2004FDA Question
04/23/2004FDA Question
06/16/2004FDA Question
10/27/2004FDA question
11/23/2004FDA Question
02/22/2005FDA Question
03/01/2005FDA Question
03/01/2005FDA Question
03/30/2005FDA Question
04/15/2005FDA Question
06/03/2005FDA Question
06/14/2005FDA question
08/30/2005FDA question
03/03/2006FDA Question
06/22/2006FDA question
10/13/2006FDA question
03/20/2007FDA Question
08/15/2007FDA question
11/08/2007FDA Question
08/27/2008FDA Question
12/31/2008FDA Question
02/03/2009FDA Question
05/06/2009FDA Question
06/03/2009FDA Question
09/23/2013FDA Question
10/17/2006FDA Question (2)
10/07/2003FDA question (Mrs. Beers Block)
11/04/2005FDA question (re 1572)
05/17/2005FDA question (re Financial Disclosure Form)
10/19/2006FDA Question- Conflict
02/04/2014FDA Question - Trial/Patient Confidentiality
03/26/2009FDA Question 1572 and Cooperative Group Studies
04/17/2009FDA Question Follow-Up of Subjects Who Withdraw
07/30/2012FDA Question Regarding Definitions
05/09/2006FDA Recognition of PAHO GCPs
04/07/2011FDA Recommended Frequency for Monitoring Clinical Trials
11/01/2010FDA Regulated Research
04/21/2010FDA Regulation for Device Central File Storage
04/27/2010FDA regulation for Device Central File Storage
12/22/2004FDA Regulation Inquiry
12/02/2010FDA Regulations, Cadaveric Material
10/15/2015FDA Regulations for Approved Drug
05/11/2004FDA Regulations for DNA Banking for Research
05/23/2008FDA Regulations Scope
07/17/2015FDA Regulatory Oversight - Prospective And Retrospective Studies
11/11/2010FDA Reporting: When the Clock Starts Ticking?
11/19/2003FDA Reporting obligations
11/28/2003FDA Reporting obligations
07/05/2005FDA reporting question
03/23/2013FDA Reporting Requirements
03/08/2013FDA Reporting Requirements for Consented Study Participants
11/18/2002FDA Requirement for CRFs pertaining to clinical trials
12/28/2005FDA Requirement for Phase 1 Unit
12/20/2012FDA Requirement Question - Follow-Up Visit Post End of Treatment.
01/12/2006FDA requirements for CROs
10/21/2015FDA Requirements for Retrospective-Prospective Research Studies
09/23/2011FDA Requirements for Study Document Storage
05/09/2008FDA Response to IRB Letter
04/01/2009FDAs Acceptance of Declaration of Helsinki
01/22/2013FDA Sites Down
12/08/2014FDA Stance on EMR and Certified Copies
03/09/2009FDA Studies
03/31/2011FDA Suspension - Clinical Hold
07/23/2015FDA Warning Letter Issued to a Clinical Investigator in France
01/09/2013FDA Website -- Current Investigator Disqualified List
12/19/2007FDA Website- Banned Devices
01/25/2010FDA Website - Therapeutic Biological Products
10/18/2014FDA Website Info
10/17/2012FDA_1572 - Usage of Local Language Characters
09/05/2012FDF Update - Financial Significant Financial Investment Dollar Amount Change
05/01/2007Feasibility in Clinical Trials
07/02/2009Federal Register IRB Registration Requirements
08/10/2004Federal Register Notices
10/10/2014Fee for Referrals to a Clinical Trial
02/08/2013F Good Clinical Practice - PDF downloads
08/26/2014Filing Contracts/Clinical Trial Agreements with Regulatory Documents
06/09/2010Filing Fees
05/06/2011Filing of Investigators to FDA
11/07/2014Filing of SIV Report at Investigator Site
07/10/2012Filling Out Form FDA 1572 Online
03/12/2012Final Guidance
07/07/2009Final Rule for IRB Registration
04/17/2008Final Study Close-Out
02/22/2007Financial Assistance
01/11/2011Financial Data
11/03/2003Financial disclosure
11/04/2003Financial disclosure
11/05/2003Financial disclosure
06/18/2004Financial Disclosure
06/10/2005Financial Disclosure
04/09/2007Financial Disclosure
04/21/2008Financial Disclosure
01/11/2011Financial Disclosure
06/01/2011Financial Disclosure
11/17/2015Financial Disclosure
03/02/2010Financial Disclosure (Study Specific vs. Sponsor Specific)
03/02/2010Financial Disclosure (Study Specific vs. Sponsor Specific)
12/20/2011Financial Disclosure - 1 Year Follow Up
01/11/2007Financial Disclosure-2
05/07/2010Financial Disclosure - Investigator
12/30/2003Financial Disclosure - Phase 4 Studies
01/09/2005Financial Disclosure and 1572 in Japan
07/31/2009Financial Disclosure and Clinical Laboratory Creds
07/10/2013Financial Disclosure and Conflict of Interest
08/21/2009Financial Disclosure by Clinical Investigators OMB #0910-0396
02/18/2005Financial Disclosure Certificate
07/07/2015Financial Disclosure Collection
08/18/2009Financial Disclosure Doubts
04/03/2013Financial Disclosure Follow up
04/22/2014Financial Disclosure Follow Up
03/23/2012Financial Disclosure for Clinical Investigators
08/01/2005Financial Disclosure for External ECG Reader
11/18/2005Financial Disclosure Form
05/18/2006Financial Disclosure Form
07/09/2007Financial Disclosure Form
07/13/2010Financial Disclosure Form
02/23/2012Financial Disclosure Form / Central Laboratory
12/05/2013Financial Disclosure Form: Covered Clinical Study
05/10/2010Financial Disclosure Form completion - Question
05/10/2010Financial Disclosure Form completion - Question
02/13/2008Financial Disclosure Forms
11/30/2010FINANCIAL DISCLOSURE FORMS
02/20/2012Financial Disclosure Forms
07/04/2011Financial Disclosure Forms - 1 Year after Trial Completion
09/20/2013Financial Disclosure Forms / Debarment Disclosure Forms in the Context of Submissions within Clinical Studies
09/30/2009Financial Disclosure Forms for Phase IV studies
02/03/2009Financial Disclosure for Phase 4 Studies
02/17/2010Financial Disclosure for Sponsor-investigators
07/02/2013Financial Disclosure for Sub-I that did not Participate
09/06/2012Financial Disclosure in a Post Approval Device Study
09/10/2008Financial Disclosure in Device Trial
01/26/2011Financial Disclosure in Foreign Studies
04/20/2012Financial Disclosure Pre-Study Collection Timeframes
04/02/2007Financial Disclosure Question
07/09/2007Financial Disclosure Question
02/26/2010Financial Disclosure Question
05/21/2012Financial Disclosure Question
01/31/2013Financial Disclosure Question
12/19/2013Financial Disclosure Question
08/22/2013Financial Disclosure Question & PHS Regs
02/16/2015Financial Disclosure Question - FDA Form 3455
04/30/2014Financial Disclosure Question on Annuities and Mutual Funds
10/20/2004Financial Disclosure questions
12/11/2012Financial Disclosure Requirements
04/17/2003Financial Disclosures
11/04/2009Financial Disclosures
11/06/2009Financial Disclosures
03/31/2011Financial Disclosures
08/05/2010Financial Disclosures by Investigators
11/01/2006Financial Disclosure Timelines
07/18/2015Financial Disclosure Update at Sponsor Change
09/18/2007Financial Interests
05/06/2008Financial Interests Forms 3454, 3455 -Questions
10/14/2005Financial Question
03/07/2005FinanDisc Form 3454
12/11/2002Finder's fees
08/17/2009Finder Fees to Subjects
10/21/2008Finding Clinical Trials
02/25/2005FinDisc and COI for IRB Members
11/27/2006Finrelations-Institutions and IRBs
07/16/2012First-to-File Generic Bioequivalent Studies Question
06/23/2014Five Day Reports of Emergency Use of a Test Article
04/12/2013fMRI Studies in the Social Sciences
05/30/2012Folding Carton Requirements
05/16/2006Follow-up at End of Clinical Trial
03/12/2013Follow-Up Contacts
01/25/2011Follow-up on FDA Proposed Guidance
06/04/2008Follow-Up on Phone Conversation Regarding Informed Consent Requirements and Subjects Approving Release of DNA Test Samples
09/13/2006Follow-up on Request for assistance in Clarifying the Difference between FDA and ICH GCPs
03/17/2014Follow-up question from SoCRA Workshop in Newport Beach
08/22/2006Follow-up Regarding Pre-Clinical Studies with Blood and Blood Components
02/27/2015Follow-up to My Questions
11/19/2013Following Up - PRIMR Conference
11/06/2008Follow Up
12/11/2008Follow Up on Emergency Research
05/24/2006Follow up to Case Report Form Query
05/17/2007Font Size
05/09/2015Food and Drug Clinical Trials Volunteer
04/30/2002Food Product Guidance
11/21/2007Foreign BIMO Regulators Inspecting US Sites
09/01/2011Foreign Clinical Data Question
03/19/2004Foreign Clinical Investigators on FDA List
10/20/2009Foreign Clinical Sites
12/15/2003Foreign clinical trial project
05/25/2004Foreign Clinical Trials
07/07/2003Foreign Data
12/18/2012Foreign Investigators
07/23/2012Foreign Site - 1572
04/21/2009Foreign Site- 1572
04/15/2009Foreign Sites 1572 Question
09/27/2004Foreign Sponsors for INDs
04/21/2008Foreign Studies the US FDA FORM 1572
09/18/2013For Help
12/18/2012Form 482
10/30/2002Form 483
01/29/2013Form 483 Response Timing
12/14/2009Form 1571 Section 11
12/20/2002Form 1572
10/08/2004Form 1572
03/18/2005Form 1572
04/01/2005Form 1572
06/23/2009Form 1572
07/16/2009Form 1572
05/31/2010Form 1572
06/14/2010Form 1572
10/18/2010Form 1572
09/20/2011Form 1572
10/13/2011Form 1572
04/06/2012Form 1572
06/04/2015Form 1572
11/11/2013Form 1572 - Continuation Page Section 3
08/07/2015Form 1572 - Listing Multiple IRBs
09/30/2008Form 1572 and Financial Disclosure Forms
06/06/2014Form 1572 and Lab Procedures Done at the Clinical Site
12/13/2011Form 1572 and Satellite Sites
08/31/2010Form 1572 Appropriateness
08/09/2013Form 1572 Box 3 and 6
01/25/2008Form 1572 Corrections Allowed
10/27/2010Form 1572 Expiration
10/04/2005Form 1572 in Foreign Studies
10/04/2005Form 1572 in foreign studies
09/24/2009Form 1572 Local Physician
01/30/2012Form 1572 Question
02/27/2012Form 1572 Question
07/08/2015Form 1572 Question
08/13/2010Form 1572 Section 3 & 6
10/01/2015Form 1572 Signature Requirements - Wet Ink or PDF
12/10/2009Form 1572 Sponsor Investigator
06/06/2010Form 1572 Update
08/28/2009Form 1572 Updating
08/03/2012Form 1572 version August 31, 2011
02/24/2012Form 1572, Box #4
11/20/2009Form 1572- Block #4
08/11/2008Form 1572- List 2 Protocols
01/18/2008Form 1572- Should One Study Site Address Be Removed
02/24/2011Form 3674 Guidance
04/06/2009Form FDA- 1572
10/24/2003Form FDA 1571
02/04/2003Form FDA 1572
02/06/2003Form FDA 1572
01/07/2005Form FDA 1572
10/14/2005Form FDA 1572
07/30/2008Form FDA 1572
07/27/2010Form FDA 1572
02/22/2011Form FDA 1572
04/07/2011Form FDA 1572
09/11/2014Form FDA 1572
06/26/2012Form FDA 1572 (2/12)
09/14/2010Form FDA 1572 - Additional Pages
09/05/2012Form FDA 1572 - Box 3 vs. Box 4
05/11/2015Form FDA 1572 - Compliance Clarifications
10/30/2007Form FDA 1572 - List of Investigators
11/10/2010Form FDA 1572 - section 4
11/29/2011Form FDA 1572 - Use of Addendum
01/21/2015Form FDA 1572 and FD retention
08/10/2007Form FDA 1572 Box 4
12/01/2011Form FDA 1572 Completion
03/07/2014Form FDA 1572 Continuation Page
02/04/2014Form FDA 1572 Continuation Pages
06/24/2009Form FDA 1572 Expiration
06/07/2010Form FDA 1572 Expired
04/05/2011Form FDA 1572 Guidance
06/10/2015Form FDA 1572 Inquiries
10/04/2002Form FDA1572 inquiry Importance: High
09/13/2011Form FDA 1572 Query
08/17/2004FORM FDA 1572 Question
04/06/2010Form FDA 1572 Question
05/16/2012Form FDA 1572 Question
06/20/2012Form FDA 1572 Question
02/28/2013Form FDA 1572 Question
09/09/2013Form FDA 1572 Question
10/01/2013Form FDA 1572 Question
05/07/2004FORM FDA 1572 Questions
12/30/2015Form FDA 1572 Questions
05/03/2004Form FDA 1572 Revision
10/01/2010Form FDA 1572 Revision Requirement Related to Unexpected/Unplanned Medical LOA by Primary PI
06/13/2012Form FDA 1572 Section 3 vs. Section 4
09/12/2002Form FDA 1572 Versions
05/28/2009Form FDA 1572- Expiration Date May 31, 2009
08/02/2005Form FDA 1572s
08/02/2005Form FDA 1572s
05/04/2010Form FDA 3455
06/22/2010Forms for Auditing Data Collected from Clinical Trial
12/13/2006Forms for Clinical Trials
07/22/2008For Profit IRBs
01/25/2010Forwarded from FDA Basics Questions
03/31/2002Found it
03/01/2010Fraud / Misconduct
09/08/2009Fraud vs. Misconduct
03/25/2013Frequency of GCP Training
09/21/2009Frequent Asked Questions - Statement of Investigator (form FDA 1572)
02/24/2012Full Legal Name on 1572 Section #1
02/09/2009Full Time Trial Subject
02/08/2005Funds Remaining After Trial
07/15/2014Fw:
05/06/2013FW: Charging Subjects in Clinical Trials
03/27/2013FW: FDA Final Rule: “Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products”
09/25/2006FW: informed consent
02/26/2013FW: IRB Registration / FWA
05/29/2014FW: Request for Medical Tool Device Clinical Trial
05/30/2013FW: Voice Message from [REDACTED]
08/01/2006FWA & IRB registration Lapse
06/17/2005FWA number
02/16/2004FWA Number and ICH-GCP - Meaning of the FWA Number
04/24/2012FWA Requirements
08/28/2006FW Clinical Trials Website
07/28/2013Fwd: External Safety Reports Not Reviewed by the PI
03/16/2012FW DrugInfo Comment Form FDA/CDER Site IRB Registration
11/30/2006FW Question
02/22/2010FW Question on Clinical Trials Registration
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07/02/2002GCP
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01/26/2009GCP
06/29/2011GCP
06/05/2012GCP
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09/26/2012GCP
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07/18/2013GCP
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09/23/2014GCP
10/08/2014GCP
06/14/2010GCP "Washout" Question
03/20/2012GCP & ICH Training Courses
02/06/2006GCP's
02/05/2007GCP-Audit Guidelines
08/09/2010GCP-Audit Related Question
11/14/2011GCP - Documents from Facilities Performing ECGs
11/10/2009GCP- Drug Labeling for Double Blind Trial
07/30/2002GCP - drugs vs. devices
05/07/2002GCP- ESSENTIALS
07/23/2013GCP - Informed Consent Language Skills
05/11/2003GCP - IRB timelines
10/18/2010GCP-Office Security
11/01/2010GCP-Pediatrics
02/01/2008GCP- Related Questions on Clinical Trials for Investigational Drug Products
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07/02/2002GCP/GLP Material
03/11/2003GCP/ICH guideline book
11/18/2011GCP/MDR Questions
11/09/2005GCP/Regulatory Questions
09/26/2002GCP 4.3.3
10/11/2011GCP: Inform Consent Procedure Guidance
10/19/2006GCP and CFR Guideline Books
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11/01/2010GCP and Consenting Process Note
02/10/2012GCP and FDA Regs
09/10/2003GCP and GMP for investigational drugs
04/25/2006GCP and Informed Consent
03/15/2010GCP and Non-Regulated Trials
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12/27/2010GCP Audit Question
06/13/2012GCP Book
03/04/2003GCP booklet
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02/20/2003GCP books
02/26/2013GCP Cert.
04/21/2008GCP Certificate
05/05/2011GCP Certificate
03/29/2002GCP Certification
09/13/2004GCP certification
09/13/2004GCP certification
09/15/2004GCP certification
09/16/2004GCP Certification
01/10/2005GCP certification
01/15/2009GCP Certification
01/07/2010GCP Certification
05/24/2012GCP Certification
06/21/2012GCP Certification
01/02/2014GCP Certification
02/13/2014GCP Certification
06/03/2009GCP Certification (2)
07/16/2009GCP Certification (3)
12/22/2010GCP Certification?
03/12/2012GCP Certification Credentials
01/27/2010GCP Certification for Clinical Investigators
06/12/2003GCP Certification for Investigators
12/10/2009GCP Certification of Investigators and Coordinators
07/25/2008GCP Certification Programs
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12/18/2007GCP Certification Training
02/27/2008GCP Clarification Queries
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03/15/2005GCP Class
06/19/2007GCP Clinical Research Question Regarding Anonymous Data Collection Study
07/09/2008GCP Clinical Trials Guidelines Document Storage
02/01/2006GCP Compliance
08/11/2005GCP Compliance - REDACTED
08/22/2003GCP Compliance question
09/20/2005GCP Compliance Question
01/26/2009GCP Compliance Question
03/25/2008GCP Compliance Questions
06/22/2011GCP Compliance Questions
07/24/2013GCP Compliance Questions
03/22/2013GCP Corrective and Preventive Action Programs- A question
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02/03/2004GCP Course
04/07/2004GCP Course
04/07/2010GCP Course
12/13/2004GCP Course Accreditation
08/31/2007GCP CRF Update Question
07/06/2012GCP Current Version
04/09/2010GCP Document
01/05/2012GCP Document Download
12/09/2004GCP Documents
01/26/2006GCP Documents
03/01/2012GCP Fed Regs HSR Separation of ICFs from Docs with Study ID Numbers
07/10/2013GCP for Nutritional Products
07/06/2011GCP for Physicians
04/20/2014GCP for Storage and Distribution
06/19/2007GCP GLP University Laboratory
04/22/2012GCP Gold Standards
09/17/2004GCP Guidance
10/09/2014GCP Guidance Document
08/07/2009GCP Guidance for PI
10/14/2008GCP Guidance on Sub-Investigator Licensing
03/01/2011GCP Guide
03/12/2010GCP Guideline Question
03/10/2003GCP Guidelines
08/02/2004GCP Guidelines
02/01/2008GCP Guidelines
04/17/2008GCP Guidelines
06/05/2009GCP Guidelines
10/18/2011GCP Guidelines
01/16/2014GCP Guidelines
01/31/2008GCP Guidelines Books- 1
10/31/2002GCP guidelines for study sites
09/12/2012GCP Guidelines on Redactions
10/15/2010GCP Guidelines Question
06/24/2010GCP Guidelines Re: Pregnancy f/u
06/13/2012GCP Handbook
06/26/2008GCP ICH Bound Manuals (Miniature Paperback Books)
07/06/2012GCP Implementation
10/19/2005GCP in 1997
03/03/2004GCP in a Histology Laboratory
06/21/2004GCP in Brazil
11/06/2008GCP Included in CFR 312
07/14/2002GCP in data management
04/02/2010GCP in FDA Regulated Trial outside US
07/13/2004GCP in Foreign Countries
02/28/2003GCP Information
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04/15/2014GCP Information Sheet
02/11/2014GCP Informed Consent Question
02/25/2004GCP inquiry
07/06/2005GCP Inquiry
05/03/2010GCP Inquiry
11/13/2009GCP Inquiry Related to Adverse Event
12/03/2003GCP in Spanish
09/10/2008GCP Inspection Findings
04/19/2006GCP in Trials of Licensed Products
11/16/2011GCP IRB Letter Guidance
04/02/2010GCP Issues on Compassionate Use
02/24/2005GCP Know How
04/25/2006GCP Lab Question
02/22/2011GCP Law Enquiry
07/23/2007GCP Literature
11/18/2005GCP Manual
06/17/2002GCP Manual for Investigator's?
11/18/2009GCP Manuals
01/14/2011GCP Manuals
01/29/2003GCP Materials for Clinical Trials
12/22/2009GCP Online Testing
07/25/2013GCP Online Tutorial
09/26/2007GCPP - Clinical Trial Archiving
06/22/2011GCP PI Training Documentation Question
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02/11/2015GCP Presentations Available
06/21/2002GCP Purchasing Manual
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08/31/2005GCP Queries
02/27/2010GCP Queries to FDA
02/12/2008GCP Query
04/14/2010GCP Query
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12/16/2010GCP Query
04/13/2011GCP Query
07/21/2011GCP Query
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06/16/2012GCP Query
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08/28/2012GCP Query
09/02/2012GCP Query
09/05/2012GCP Query
09/06/2012GCP Query
09/10/2012GCP Query
06/08/2011GCP Query - COA at/in the Site TMF
12/08/2009GCP Query on FDA 1572
01/27/2010GCP Query on ICF Process
12/11/2009GCP Query Regarding a CI Who Moved
06/04/2002GCP Question
08/08/2002gcp question
12/18/2002GCP Question
03/05/2003GCP question
03/10/2003GCP question
04/03/2003GCP Question
04/08/2003GCP Question
07/14/2003GCP Question
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10/24/2003GCP Question
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11/20/2007GCP QUESTION
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12/04/2013GCP question
05/05/2014GCP Question
07/02/2014GCP Question
02/03/2015GCP Question
01/12/2010GCP Question - Applicability to Non-IND Studies
05/20/2008GCP Question- Auditing
02/22/2011GCP Question-Blood Work
08/19/2011GCP Question - Dosing
01/06/2014GCP Question-Informed Consent
08/22/2012GCP Question - Lost to Follow-Up
07/03/2008GCP Question- Note to File
07/23/2002GCP question - pt. compensation
03/03/2011GCP Question-Records
06/11/2009GCP Question- Subject Entry Into a Study
06/26/2015GCP Question...
04/10/2015GCP Question/EC chairman
02/03/2010GCP Question/Legally Acceptable Representative (LAR)
02/03/2010GCP Question/Legally Acceptable Representative (LAR)
02/03/2010GCP Question/Legally Acceptable Representative (LAR)
06/05/2014GCP Question: New Safety Information to be Disclosed to Study Participants
02/19/2015GCP Question: TMF
11/01/2011GCP Question about
09/09/2015GCP Question about 21 CFR Part 11
01/27/2010GCP Question about 1572s
04/11/2008GCP Question About Non-Clinical Record Retention
02/20/2013GCP Question about Training
02/20/2013GCP Question about Translation
06/27/2013GCP Question Concerning Clinical Trial Supplies
01/16/2008GCP Question Drug Accountability
03/31/2014GCP Question for Source Data
09/20/2012GCP Question Obligation of Investigator Serious Adverse Event
03/10/2011GCP Question on ICF
10/10/2008GCP Question on PRO Source Data
02/20/2014GCP Question on Referencing Text across ICFs
05/26/2009GCP Question on SOP's and Training
04/07/2008GCP Question on Training Frequency
06/27/2011GCP Question Re: Clinical Testing Laboratory
05/23/2013GCP Question re: Essential Documents
01/17/2011GCP Question Re: Investigational Product
10/09/2013GCP Question RE: Sponsor's Essential Document Maintenance
01/26/2011GCP Question re: Sponsor Intervention in Clinical Trial Conduct
03/16/2015GCP Question regarding a Delegation Log
07/21/2004GCP Question Regarding Enrollment of Investigators in a Clinical Trial
01/29/2007GCP Question Regarding Incentives
09/25/2012GCP Question regarding Use of Notes to File as Essential Documents
06/26/2013GCP Question regarding “Current” Investigator CV
12/13/2007GCP Question Re Imaging Reading Services
11/23/2011GCP question related Site Signature Sheet (Delegation Log)
11/22/2013GCP Question related to IRB Access to Medical Records
12/12/2006GCP Question Relating to ICF
08/31/2007GCP Question Re Retrospective Data Collection and ICF
04/03/2002GCP Questions
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11/06/2002GCP Questions
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11/19/2015GCP Questions
08/17/2010GCP Questions - Financial Disclosure
08/17/2010GCP Questions- Financial Disclosure
07/23/2014GCP Questions - Investigator Record Retention Requirements
08/26/2008GCP Questions Collection of CVs FD and 1572
07/24/2013GCP Questions concerning Protocol Signature Pages and Local IRBs
11/11/2013GCP Questions Link
07/26/2007GCP Questions Pregnancies
02/23/2006GCP Questions Re Compliance
04/03/2013GCP Questions related to Consent Withdrawal
09/04/2013GCP Questions related to Consent Withdrawal
11/02/2006GCP Question Study Staff in Trial
08/06/2015GCP Re-Cert
05/23/2013GCP Recommendations
03/05/2013GCP Refresher Training
04/18/2012GCP Regulation
02/11/2009GCP Regulations- Clinical Labs
10/07/2002GCP Regulations and Law
01/29/2014GCP Regulations or Guidelines?
03/03/2003GCP regulations pamphlet
08/17/2011GCP Regulations Preambles
02/11/2004GCP regulatory issues
03/25/2010GCP Related Question
03/30/2010GCP Related Question
04/22/2010GCP related question
04/08/2009GCP Related Question for Observational Study
04/17/2009GCP Related Question for Observational Study 2
03/11/2015GCP Renewal
09/11/2013GCP Renewal Training
05/09/2003GCP Request
02/06/2012GCP Requirement
05/08/2014GCP Requirement?
06/03/2009GCP Requirement Query
10/15/2013GCP Requirements for Study Staff
12/10/2004GCP re Source Documents in a Clinical Trial
08/06/2013GCP Retraining
05/22/2015GCP Retraining
09/23/2014GCP Sections for Laboratories
12/01/2010GCPs ICH 5.18.6
09/28/2011GCPs Online Trainings
10/06/2005GCP Source Documentation Questions
09/06/2012GCP Speaker
03/16/2005GCP Speaker?
07/15/2002GCP Standards
07/15/2002GCP Standards
03/03/2006GCP Status of ICH
11/29/2006GCP Systems Audits
05/02/2008GCP Telephone Audits
10/13/2002gcp training
02/10/2003GCP Training
06/27/2003GCP training
06/09/2004GCP training
08/25/2004GCP Training
12/09/2004GCP Training
12/09/2004GCP Training
07/03/2008GCP Training
10/20/2009GCP Training
01/19/2010GCP Training
04/21/2010GCP Training
08/13/2010GCP Training
08/23/2010GCP Training
10/20/2010GCP Training
11/29/2010GCP Training
01/31/2011GCP Training
05/12/2011GCP Training
05/25/2011GCP Training
10/13/2011GCP Training
11/14/2011GCP Training
11/29/2011GCP Training
12/15/2011GCP Training
04/18/2012GCP Training
08/03/2012GCP Training
08/09/2012GCP Training
08/09/2012GCP Training
09/09/2012GCP Training
10/04/2012GCP Training
04/19/2013GCP Training
04/23/2013GCP Training
11/26/2013GCP Training
07/26/2014GCP Training
07/30/2014GCP Training
11/19/2014GCP Training
06/17/2015GCP Training
07/20/2015GCP Training
12/21/2015GCP Training
12/24/2015GCP Training
09/05/2011GCP Training & Certificates
06/03/2009GCP Training (3)
09/15/2011GCP Training - Expiration
08/12/2015GCP Training / IRBs
11/21/2006GCP Training 2
06/12/2009GCP Training and Certification
09/23/2005GCP Training and Certification?
11/16/2007GCP Training and Qualifications
01/07/2013GCP Training and Testing Materials
09/13/2013GCP Training Compliance
06/25/2010GCP Training Course
09/07/2011GCP Training Courses
09/22/2015GCP Training Documentation
12/27/2010GCP Training documentation at investigational site
07/09/2014GCP Training for IND Trial
01/19/2011GCP Training for Investigators
06/15/2012GCP Training For Investigators and Coordinators
05/26/2011GCP Training for Investigators and Site Staff
12/15/2005GCP Training for REDACTED Research Professionals
04/17/2015GCP Training for Site Staff
04/17/2015GCP Training for Site Staff
08/05/2013GCP Training Frequency
06/19/2014GCP Training Frequency
01/26/2010GCP Training Guidelines
04/22/2004GCP Training Information
03/29/2005GCP training inquiry
06/03/2011GCP Training in [redacted]
01/16/2012GCP Training Modules
08/18/2009GCP Training Programs
02/17/2010GCP Training Question
03/28/2014GCP Training Question
12/15/2011GCP Training Requirements
04/08/2014GCP Training Requirements
12/17/2015GCP Training Requirements
02/29/2012GCP Training Requirements - How often is a PI Expected to Retrain
10/06/2011GCP Training Tools
08/11/2011GCP Training Websites
09/27/2010GCP Train the Trainer Course
11/14/2012GCP Update?
07/25/2010GCP Validation Requirements
04/11/2011GCP versus local law
03/14/2003GCP vs CFR
05/12/2011GCP vs GLP
11/14/2003GCP vs GMP
08/06/2003GCP Warning Letters
08/01/2013GDUFA - Who is required to Self-Identify
10/16/2003General
04/15/2010General Administration Practices
10/03/2002general advertising for clinical trials
08/27/2004General GCP Question
12/09/2002general question
12/20/2002General Question
09/12/2007General Question
01/04/2010General Question
06/07/2010General Question
01/23/2012General Question
11/11/2013General Question about Biomarker Tissue Samples and Chain of Custody
10/16/2002General question about Informed Consent
07/25/2011General Question on IRB Approval without an IND and Clinical Hold and Global PI Responsibility
04/30/2004General question regarding an Informed Consent for an IDE study
02/10/2014General Question regarding Re-Consenting of a Subject
10/28/2011General Questions
09/16/2002General questions regarding Good Clinical Practice
11/09/2010General Question to Inclusion of Patient
11/05/2007Generic Phone Scripts
11/05/2008Generic Phone Scripts
07/16/2015Generic Pre-Screen ICF
03/05/2007Generic Recruitment Materials
02/06/2009Genetic Testing Associated with Clinical Research
06/07/2013Genetic Testing Link for GCP Questions
02/17/2015Geriatric Population
09/18/2013Getting involved in Clinical Trials
07/14/2003GGP question
03/28/2003Gifts for investigators
11/30/2007Gifts to IRB
12/07/2006Gifts to Subjects
11/05/2010GINA
10/06/2005Glossary
11/20/2013GLP & GCLP
09/30/2002GLP and GCP
08/03/2002GLP for clinical trials
09/11/2003GLP in the GCP
10/09/2003GMP/GCP Question
12/07/2004Good Clinical/Laboratory Practice Question
12/07/2004Good Clinical/Laboratory Practice Question
05/24/2005Good Clinical Practice
02/07/2006Good Clinical Practice
07/02/2008Good Clinical Practice
03/09/2010Good Clinical Practice
11/23/2011Good Clinical Practice
12/07/2012Good Clinical Practice
10/14/2014Good Clinical Practice
06/14/2015Good Clinical Practice
11/12/2003Good Clinical Practice (GCP) Monitoring Guidelines (1988)
01/30/2013Good Clinical Practice, Human Subjects
01/27/2011Good Clinical Practice-Investigator Signatures
02/04/2013Good Clinical Practice / ICH
01/27/2010Good Clinical Practice Certificate
01/14/2014Good Clinical Practice Education
03/12/2010Good Clinical Practice Guidelines
11/16/2011Good Clinical Practice Guidelines
03/26/2008Good Clinical Practice in Pediatric Population
02/18/2011Good Clinical Practice Policy and Regulation
08/10/2004Good Clinical Practice Question
09/30/2015Good Clinical Practice Question
05/31/2013Good Clinical Practice Regulations
05/16/2011Good Clinical Practices
01/17/2015Good Clinical Practices
11/22/2012Good Clinical Practices Guideline
10/31/2003Good Clinical Practices Guidelines Handbook
12/07/2007Good Clinical Practices Question
11/24/2009Good Clinical Practices Question
04/30/2003Good Clinical Practices Training
06/21/2006Good Clinical Practice Training
12/03/2009Good Clinical Practice Training
07/31/2002Good Clinical Practice Training on site?
11/11/2013Good Documentation Guidance Document
12/06/2010GPC: Certification/Accreditation Question
06/21/2012GPC Question
03/26/2009Grading Scales
07/11/2005Grant
02/05/2008Group Consents
03/10/2004Guidance
09/07/2004Guidance
11/02/2004Guidance
08/31/2005Guidance
07/12/2006Guidance
04/05/2012Guidance
03/19/2013Guidance
10/01/2015Guidance
09/22/2008Guidance-Frequently Asked Questions-FDA 1572 Form
10/14/2009Guidance-Phase 1 Trials
10/21/2004Guidance Doc on Site Incentives
02/04/2011Guidance Document
11/15/2010Guidance Document -1572/Delegation of Authority
02/20/2009Guidance Document for Form FDA 1572
05/11/2009Guidance Documents
01/10/2013Guidance Documents on Certified Copies
04/04/2002guidance documents reproducibility requirements for clinical trials
09/09/2004Guidance for Cancer Drugs
05/31/2011Guidance for Clinical Study Monitoring
07/03/2012Guidance for Clinical Trial Sponsors Expiration Date
05/18/2011Guidance for Enrollment of Out of Town Subjects
05/30/2007Guidance for Exception from Informed Consent Requirements for Emergency Research
12/01/2005Guidance for Industry: Computerized Systems used in Clinical Trials
04/07/2011Guidance for Industry: Financial Disclosure by Clinical Investigators
08/12/2003Guidance for Industry part 11 (merely incidental use of computers, legacy system)
09/24/2015Guidance for Line 4 of 1572
09/16/2015Guidance for Sponsor- Investigators of INDs
03/22/2012Guidance for sponsors, Investigators and IRBs - Q&A - Request for [redacted] [redacted] CRO
01/04/2010Guidance for Use of Data in Specific Situations
06/28/2010Guidance from FDA
08/30/2010Guidance in Audit or Site Review of Investigator-Initiated Studies
07/15/2011Guidance Needed
06/26/2009Guidance on Announcing Clinical Trial Results
12/12/2012Guidance on Clinical Trial Record Storage with Blinded Materials
07/18/2012Guidance on Clinical Trials
07/25/2011Guidance on Enrolling a Prisoner in a Clinical Trial
10/02/2015Guidance on FDA Form 1572 Question
01/31/2011Guidance on FDA Requirements
05/24/2013Guidance on GCP
12/04/2012Guidance on IP Storage for Purposes Other Than Use in Clinical Trial(S)
07/26/2011Guidance on IRB Minutes and the Conduct of IRB Meetings
11/02/2011Guidance on Monitor Queries
10/08/2008Guidance on QTQTc Interval
03/12/2008Guidance on Screen Failures
07/18/2012Guidance on Site Equipment
05/01/2013Guidance on Site Reimbursement during Clinical Trials
04/10/2014Guidance on Sponsor Request
06/08/2010Guidance on Third Parties Working on Trials in Sites
12/01/2011Guidance on Utilizing Social Media for Clinical Research Participant Recruitment
01/25/2008Guidance Practices Regarding Enticement
11/04/2003Guidance Question
12/28/2006Guidance Question
10/22/2013Guidance regarding an IRB Issue with a PI Resignation
12/06/2012Guidance regarding IRB's Policy for Review of All Unanticipated Adverse Device Effect Reports by the Convened IRB
10/20/2008Guidance Regarding Sponsor Contact Involvement with Study Patients
01/08/2008Guidance Re Non-English Reading Subjects
03/19/2011Guidances and Policy
05/11/2009Guidance v Regulations
12/16/2008Guideline For Number Of Trials To Conduct- Different Regions
08/07/2007Guideline for PI' s CV
04/05/2011Guideline for Record Keeping of Clinical Trial
04/08/2011Guideline for Record Keeping of Clinical Trial
12/11/2009Guideline for Sponsor's Study Coordinator
12/16/2011Guidelines/Regulations of Unblinding of Participants
11/07/2006Guidelines About Facilities for Phase 1 Clinical Trials
12/16/2008Guidelines Clinical Trial Registries
09/23/2011Guidelines for Advertisement of a Clinical Study
08/30/2002guidelines for archiving of biological samples
01/26/2012Guidelines for GCP Training for Sub-investigators
03/24/2004Guidelines on Source Data Verification in Clinical Trials
09/04/2003Guidelines re: notes to file vs. amendments
05/20/2004Guidelines to Follow
05/16/2007Guidelines vs. Regulations
01/26/2006Guide to Good Clinical Practice
05/14/2012Gummy Bear Implants
07/24/2014HACCP Regulation for Fish and Fishery Products
12/17/2008Hand-Dating 1572
03/25/2002handbook
08/06/2014Handling of Unsolicited Contacts from Patients
11/28/2006Handling Patient Diary Data
02/19/2015Handwriting and Typed on the Same 1572.
01/28/2008Hard Copy of Patient Notes
01/26/2005Hard Drive Encryption
12/14/2005Harmonization
02/13/2006Has 9-04 Guidance Been Finalized
06/03/2014Has there been any changes since we contacted you last year?
11/10/2002Have some question
06/12/2009HDE Data Safety Monitoring
04/17/2007Headaches As AEs
04/02/2005Health - Conflict of Interest
12/27/2006Health Services Research
04/26/2012Hello
08/06/2012Hello
09/29/2014Hello and Request for Clarification
04/23/2002Help
03/21/2011Help
05/12/2011Help
08/24/2009Help!
03/25/2004Help!! (on an Investigator's Brochure)
11/17/2014Help, Need some File
03/24/2009Help Finding a Document
12/27/2006Help in Obtaining Certificates of Confidentiality
03/27/2008Help with FDA GCP Rules
10/29/2010Helsinki
01/22/2015Helsinki Declaration Last Version in INDS Clinical Protocol
01/23/2009Helsinki Version
12/12/2006HHS Conducted Funded Research by FDA
09/13/2002Hi
11/30/2005HIPAA
06/13/2007HIPAA
03/04/2003HIPAA & foreign locations (Canada)
11/05/2009HIPAA and Contact Info
12/03/2012HIPAA and Our Participants
12/03/2012HIPAA and Our Participants
03/02/2011HIPAA and Relocating Research Charts
04/07/2003HIPAA authorizations and IRB responsibilities
04/05/2004HIPAA Compliance
04/08/2010HIPAA Forms
02/04/2015HIPAA Inquiry
05/13/2003HIPA and the release of participant information to the participant prior to the close of a blinded clinical trial
05/08/2009HIPAA Not Signed by Subject - Can Data Be Used
02/28/2003HIPAA Question
05/28/2009HIPAA Question
02/27/2015HIPAA Question
06/05/2009HIPAA Question- Electronic Health Record
02/06/2012HIPAA Question for FDA-Regulated International Studies
08/29/2002HIPAA Question on CRO and Monitor Responsibility
11/04/2002HIPAA questions
06/30/2003HIPAA Questions
11/29/2012HIPAA Regulations
02/09/2011HIPAA Related Questions
11/29/2007HIPAA Subject Name to Travel Agency
08/18/2003HIPAA vs a medical release
08/23/2011HIPPA question
02/04/2013HIV Testing in Protocols
12/16/2004HIV Testing Inquiry Response
04/01/2008Hold on [Redacted] Question
02/26/2013Home Health Agency on 1572
10/21/2014Home Health Care Provider and 1572
10/20/2011Homeless Population
12/05/2012Home Visits
08/28/2006Hospital Medical Records
02/18/2004Hospital Membership Update with FDA
10/22/2009Hospital Names on Form 1572
01/15/2010Hospital Regulation & Data Reporting re: Hospital Acquired Infections
03/11/2005Hospital Responsibility in Research
03/17/2005Hospital Responsibility in Research
09/11/2014How Can I take the Course for GCP ASAP?
08/20/2004How do I become a qualified clinical investigator?
09/18/2013How Do I Get Started Doing a Clinical Trial
12/21/2012How Do We Get A Copy of GCP Regulations or Guidance?
05/28/2008How Many Studies Can CI Conduct
02/01/2006How Much Patient History is Enough?
03/28/2006How Often Should Info Be Collected
05/01/2015How should Investigators Maintain Case Histories?
07/05/2011How to Become/Register as a CRO
03/04/2010How to become Investigator in Trial
07/11/2012How to Blind a Clinical Trial
04/17/2012How to Complete eCRFs Properly
12/15/2010How to Correct GCP Error
02/20/2015How to Correct the Medical Charts
08/04/2009How To Find Out About Clinical Trials
03/07/2006How to Participate as CI in Clinical Trials
04/19/2014How to Participate FDA Approved Clinical Trial
10/03/2010How to Properly Sign and Date Signatures per GCP
04/17/2012How to Refer To a Clinical Trial Results
09/07/2007HUD Question
11/24/2003Humanitarian Use Devices - FAQ?
07/16/2007Human Participant Protections Education
11/12/2004Human Research Professionals Presentations
02/23/2003Human Research Question - FDA
02/06/2008Human Serum Plasma Samples
09/28/2011Human Subject Inform Consent Question
05/05/2004Human Subject Protection/Good Clinical Practices Steering Committee
11/04/2005Human Subject Protection Certification
03/07/2007Human Subject Protection Policy Help
02/11/2003Human subject protection training
07/23/2008Human Subject Protection Training
02/11/2008Human Subjects Protection Training
07/25/2003Human Subjects Research Certification
12/28/2010Human Subjects Training
05/16/2012Human Subjects Training Requirements
09/13/2013Human Tissue Analysis
09/14/2013Human Tissue Analysis
08/18/2011Hypothetical Related to Study Design and FDA Regs
11/19/2012I'm looking for a Treatment
08/07/2015I/E Criteria not included in Protocol
02/27/2011I Am a Patient on a Study
12/17/2012I Am Writing to Ask About the Arrangement of Clinical Trial Site
08/01/2002IATA FAA Regulations For Hazardous Materials
07/08/2010IATA Training
08/13/2014IATA Training Documentation
05/13/2008IB Question
04/05/2005IBs
04/22/2011IB Updating
10/31/2007IC- Blind Subject
05/17/2007IC-Multi-Site Trials
04/09/2007IC- Test Article Safety
11/24/2009IC- Using an Alias
08/09/2007IC Documentation
03/10/2010ICF
02/10/2011ICF
01/23/2012ICF
06/19/2009ICF-Witness Date Questions
07/29/2013ICF and delay in Study Procedures
10/03/2012ICF Concern
03/30/2012ICF Exception
10/13/2011ICF for non-English Speaking Patients
06/14/2012ICF GCP Question
03/06/2015ICF in EMR
10/16/2012ICF New Requirement
09/25/2013ICF Process Documentation in Subject Records
06/12/2006ICF Process for a Non-English Speaking Person
02/16/2012ICF Process Question
03/25/2009ICF Query
06/23/2011ICF Query
09/02/2013ICF Query
06/14/2011ICF Query Principal Investigator Designation
12/28/2010ICF Question
03/28/2012ICF Question
03/27/2014ICF Question
11/04/2014ICF Question
09/09/2011ICF Question - Is reimbursement for expenses the same as payment for a study subject?
03/25/2013ICF Question - Missing Page
02/08/2011ICF Question Regarding non-English Speaking Subject
06/05/2014ICF Question Re Procedure Location
01/26/2015ICF Requirement regarding Alternative Therapy
05/10/2011ICF Requirements for SOC Procedure
07/31/2002ICFs
09/25/2007ICFs and Central vs. Local IRB
08/28/2014ICF Short Form
03/05/2003ICF source documentation
09/09/2015ICF Translations
02/21/2011ICF Updates
11/27/2009ICF Withdrawal from Study Treatment
09/28/2006ICF Witness
08/16/2012ICH-GCP
10/09/2012ICH-GCP
03/31/2011ICH-GCP Contract Language and Protocol Language
09/16/2004ICH-GCP E6 Section 8 point 8.3.17 and 8.3.19
08/25/2005ICH -GCP Protocol Requirements
08/02/2004ICH/GCP
07/11/2005ICH/GCP
10/16/2015ICH/GCP #5.8.1 - Request for Clarification
10/07/2013ICH/GCP Question re: Site Initiation
11/30/2011ICH/GCP Training at Clinical Sites
12/01/2011ICH/GCP Training at Clinical Sites
01/06/2010ICH4.8.9 Signing of ICF
11/12/2010ICH E6 and ISO 14155 Differences
11/08/2010ICH E6 Document Online
07/19/2012ICH E6 Section 4.9.3
07/19/2012ICH E6 Section 4.9.3c
02/15/2013ICH E6 Section 8: Essential Documents for the Conduct of a Clinical Trial
04/21/2014ICH E11 Question about Pediatric Experts
11/02/2007ICH GCP Essential Documents Logs Needed
05/25/2007ICH GCP Guideline 312.62
06/03/2005ICH GCPs
06/29/2011ICH GCP Violations
11/22/2005ICH Good Clinical Practice Guidelines
09/16/2008ICH Guidance and Combination Products
03/13/2006ICH Guidance Documents
10/04/2005ICH Guidance on GCP
07/05/2006ICH Guidance on InvBrochure
08/20/2004ICH Guidelines
08/17/2004ICH Guidelines/Good Clinical Practice and Code of Federal Regulations Book
04/12/2007ICH Guidelines Clarification
12/10/2008ICH Impact on GCP
04/24/2008ICH Question
05/08/2008ICH Question- 2
04/04/2008IC Non-English Speaking Subjects
05/02/2007IC Translation Service
10/23/2012IDE/IRB Question
03/05/2008IDE and MDRs by User Facilities
03/25/2009IDE Devices Post FDA Approval
02/28/2012IDE Final Report
01/19/2010Identifying Research Patients
12/15/2006Identify Sponsor in Consent Form
03/27/2012IDE Protocol
03/14/2012IDE Question
06/27/2012IEC/IRB Physical Meeting Necessary?
01/28/2009IEC Approval in Clinical Trial
05/29/2008If 1572 Update Needed
12/07/2011If the Physician could be an Investigator
03/14/2012If Unblind Study Nurse Could Make CRF Entries and Corrections
06/07/2012IGC-GCP section 3.2.1
06/17/2010IGS Regarding NDA
09/22/2004I have a Question
09/12/2013I have a Question
06/20/2005IHC Query
08/19/2010IIS/IIT study Responsibilities
01/15/2013IIT-PI Responsibilities as Sponsor when Study is IND or IDE Exempt
03/05/2007IITs
12/08/2006Illegal Alien As a Subject
12/11/2009Illiterate Subject and Informed Consent
11/05/2013Images, CD/Printed Copy Question
08/30/2010Imaging Facilities on 1572
10/29/2015Immediate Termination of Principal Investigator
06/21/2002Impact of HIPAA on Conduct of Clinical Trials
06/06/2006Impaired Physicians
11/23/2009Impartial Witness
02/17/2010Impartial Witness
03/01/2010Impartial Witness
03/18/2013Impartial Witness
07/28/2014Impartial Witness
06/03/2014Impartial Witness Definition
11/02/2007Impartial Witness Expectation
01/29/2013Impartial Witness Presentation - NIDPOE - CI Violations
04/14/2010IMP at Site and Site Initiation
02/15/2013IMP Labeling Question
06/10/2015IMP Labeling Requirements in USA
08/28/2006Implied Consent Form
01/06/2009Importance of Source Documents
05/12/2005Important Question
03/20/2009Important Questions
09/19/2008Importing Investigational Drugs
08/08/2008Incentives and Bonuses
08/08/2008Incentives and Bonuses
07/14/2006Incentives for Enrolling Subjects
08/01/2013Include a Mexican Clinical Site under a FDA-Approved Trial
11/01/2013Including Drug Risks in a Registry Study
05/05/2006Inclusion-Exclusion Criteria
03/01/2015Inclusion/Exclusion
02/28/2005Inclusion/Exclusion Criteria
04/06/2011Inclusion/Exclusion Criteria
06/14/2005Inclusion/Exclusion Criteria for Study Subjects
02/17/2011Inclusion and Exclusion criteria and Use of Expired Form 3455
12/07/2006Inclusion of Alzheimers Patients
09/08/2008Inclusion of Sponsor Investigator Data in Industry Report
05/13/2014Inclusion of Sub-investigators on 1572
02/14/2006Inclusion of Women in Clinical Trial
06/06/2002inclusion of women of child-bearing potential
11/18/2009Incomplete Informed Consent Procedures Outside Protocol
08/13/2010Incorrect Warning Letter Citation
01/21/2011Increasing Subject Recruitment in an Ongoing Study Due To Higher Than Expected Drop-Out Rate
01/05/2005IND
12/08/2006IND # Verification
10/08/2003IND - protocol amendment
02/06/2014IND And IDE Validation Question
07/31/2003IND application
05/03/2011IND Application
06/23/2009IND Application and Protocol
09/10/2009IND Authorized Representative
03/24/2008IND Contracted Site Inconsistent Data
09/08/2015IND Database
03/02/2006IND Data Retention Issue
11/09/2006Independent Blinded Reviewers 2
06/17/2005Independent vs Local IRBs
12/20/2013IND Exemption
06/04/2015IND Exemption
08/01/2013IND Exemption and AE reporting to FDA
07/24/2014IND Exempt Required Regulatory Documents
07/02/2008IND Exempt Study and IC Electronic Signature
01/10/2010Index of Laws on Health Care Research
06/13/2002IND Financial Requirements
05/09/2008IND Form 3674
01/25/2004IND Guidance for University of Pittsburgh IRB
01/25/2004IND Guidance for University of Pittsburgh IRB
04/07/2006IND Information
02/14/2006IND Investigator Brochures
07/10/2009IND Labeling
07/25/2007IND Labeling Requirements
04/01/2013IND Medwatch and SUSAR Reporting Question
08/16/2007IND Medwatch Reports
04/10/2008IND Needed
09/19/2006IND Number
09/24/2004IND Phase II Reports
09/11/2003IND Question
04/09/2004IND question
02/17/2006IND Question
09/09/2011IND Reports for Multi-site Studies
08/21/2003IND Reports to local academic IRB
01/05/2011IND Requirements
05/25/2007INDs - 30 Day Period - Recruitment Question
10/25/2006IND Safety Letters
12/02/2008IND Safety Letters to the IRB
05/02/2005IND Safety Report
04/04/2006IND Safety Reporting
04/14/2014IND Safety Reporting
02/01/2006IND Safety Reporting Period
07/10/2007IND Safety Reporting to Central IRBs
11/16/2015IND Safety Report Policy
07/10/2003IND Safety Reports
11/18/2004IND Safety Reports
03/01/2012IND safety reports
02/21/2011IND Safety Reports - Investigator Responsibilities
11/18/2005IND Safety Reports IRB Procedures
11/21/2005IND Safety Reports Question
03/02/2006IND Safety Reports Question
05/01/2007INDs and NDAs
08/12/2013IND Sponsor Responsibility Question
06/25/2013IND Sponsor Transfer
06/30/2004IND Study
06/06/2008IND Study Non-US Investigator Reluctant to Include FDA GCPs In Contract
07/19/2011IND Study Regulatory Review Question
12/16/2005IND Submission Questions
05/09/2011IND Trial (Unclassified)
05/05/2006Industry Practice of Authorizing Exemptions to Protocol Inclusion Exclusion Criteria
01/25/2004IND Verification Question
03/26/2015IND Waiting Period
05/26/2015IND Waiver Question
04/02/2003IND with an exemption
05/18/2009IND [Redacted] Use
02/06/2013Infant Apnea Monitor Testing
10/16/2002Info
05/16/2012Info
02/19/2004Info About Expanded Access Studies
05/13/2004Info for 1572 Form
01/11/2007Info if 1572 Required
06/11/2008Info in Clinical Trials Database
05/05/2014Info Needed
09/22/2008Information
02/05/2009Information
02/25/2010Information about GCP
11/22/2005Information about Investigator Fraud
06/26/2008Information About Ongoing Clinical Trials
02/20/2013Information about Porcine Gelatin
11/10/2015Information about Randomized Manikin Study and Ethical Board
04/15/2013Information Good Clinical Practice
07/16/2009Information Guests Attending Clinical Trial Meetings Investigator
07/15/2005Information Needed
02/03/2006Information on 21 CFR Part 11
09/14/2007Information on 1572s
10/12/2011Information on a study procedure
03/08/2013Information on Clinical Trial Site Requirements
12/21/2007Information on Drug Products in Clinical Trials
02/26/2010Information on Foreign CR Requirements
07/22/2012Information on GCP
04/04/2002Information on GCP training
04/04/2002Information on GCP training
05/23/2014Information on Obtaining Training and Certificate of Training on GCP from FDA
09/03/2010Information on Study on Hold
06/01/2004Information re: charging for an investigational product
10/30/2008Information regarding [Redacted] Requirements of Unanticipated Problems
02/22/2013Information related to GCP Certification Courses
04/07/2010Information Request
11/01/2010Information Request
02/03/2015Information Request
03/30/2011Information Request regarding Critical GxP Data Storage
06/10/2005Information required
06/29/2011Information Required Related With Delegation of Duties and Abnormal Lab Values
12/01/2010Information Required Related with Informed Consent Form (ICF)
09/09/2011Information Requirement
01/14/2014Information Resources
08/03/2009Information Sheet Guidance on Payments to Study Subjects
07/23/2009Information Sheet Regarding Payment to Research Subjects
03/09/2006Information to be Included on Labels for Clinical Trial Drug Supplies
01/04/2005Information versus Advertising
03/27/2002Informed consent
03/27/2002Informed consent
06/25/2002informed consent
08/21/2002Informed Consent
08/21/2002Informed Consent
10/30/2002informed consent
02/20/2003Informed Consent
04/04/2003Informed consent
02/20/2004Informed Consent
08/28/2006Informed Consent
01/25/2007Informed Consent
03/24/2009Informed Consent
01/07/2010Informed Consent
01/27/2010Informed Consent
01/27/2010Informed Consent
04/27/2010Informed Consent
07/28/2010Informed Consent
09/24/2010Informed Consent
02/01/2011Informed Consent
06/21/2011Informed Consent
07/20/2011Informed Consent
05/30/2013Informed Consent
06/12/2013Informed Consent
11/11/2013Informed Consent
02/27/2014Informed Consent
07/16/2014Informed Consent
07/30/2014Informed Consent
09/30/2014Informed Consent
08/10/2015Informed Consent & Collecting AEs?
06/23/2009Informed Consent (Eligibility)
01/09/2007Informed Consent- Date of Signature
07/02/2008Informed Consent- Exception for Emergency Research
12/18/2009Informed Consent- Illiterate Subjects for Non-therapeutic Trials
10/21/2015Informed Consent- Items other than Study Drug Given to Subject
10/13/2015Informed Consent - Patients under 18
10/31/2006Informed Consent- Reconsenting
02/27/2007Informed Consent - Subject Copy
06/23/2014Informed Consent-Timeliness of Reconsenting
10/20/2003Informed Consent/Patient Protection
03/27/2014Informed Consent 21 CFR 50 (Part D)
06/19/2009Informed Consent After Anesthesia
12/10/2002Informed Consent Amendments Via telephone and Follow-up in Mail
12/08/2015Informed Consent and Acceptance of Foreign Data
03/05/2007Informed Consent and Enrollment
05/05/2004Informed Consent and Expiration
02/26/2007Informed Consent and NY Minor Laws
01/21/2010Informed Consent and PI Participation
12/15/2008Informed Consent and Re-Screening
12/15/2006Informed Consent and Requiring Fasting for Visit 1
08/05/2013Informed Consent and Risks for Standard of Care Procedures
10/14/2014Informed Consent and Screening
04/29/2008Informed Consent and Violations
02/10/2012Informed Consent Best Practice
10/31/2012Informed Consent by LAR with Lack of Subject Consent to Follow
02/04/2015Informed Consent Content - GCP - "Timely Manner"
06/21/2007Informed Consent Dispensing Meds
11/19/2013Informed Consent Documents
07/11/2002Informed Consent Document Storage
08/02/2011Informed Consent Expiration
02/20/2009Informed Consent for an Illiterate Decisionally Impaired Subject
03/07/2008Informed Consent for Child
07/28/2010Informed Consent for Illiterate Subject
05/25/2007Informed Consent Form
09/27/2010Informed Consent Form
06/27/2013Informed Consent Form
01/17/2013Informed Consent Form: Translations & Back Translations
05/02/2013Informed Consent Form and clinicaltrials.gov
12/07/2011Informed Consent Form execution
12/07/2011Informed Consent Form Execution
01/10/2010Informed Consent Form Question
03/26/2013Informed Consent Form Question about Overwrites
12/18/2002Informed Consent Form questions
11/24/2006Informed Consent Form Readability Guidelines
04/02/2003Informed Consent Forms
04/11/2006Informed Consent for Re-Screens
04/25/2006Informed Consent from a Blind Individual
11/24/2009Informed Consent in Acute Studies Definition of Source Data
01/10/2008Informed Consent in Clinical Trials
12/07/2010Informed Consent in Clinical Trials
08/20/2009Informed Consent Inclusion Exclusion
07/16/2014Informed Consent Information Sheet Draft Guidance
10/27/2011Informed Consent Inquiry
01/23/2012Informed Consent Inquiry
04/29/2014Informed Consent Inquiry
04/07/2010Informed consent in subjects with wavering capacity
12/13/2011Informed Consent Issue
06/26/2006Informed Consent Issues
11/07/2012Informed Consent not Feasible for Non-IVDD Study involving Deidentified Tissue Samples
11/18/2010Informed Consent Obtaining Information after Withdrawal of Consent
04/03/2008Informed Consent of an Illiterate Subject
06/25/2009Informed Consent of Cognitively Intact Quadriplegic Subjects
08/12/2015Informed Consent Outside the US and 50.25C
04/18/2003Informed Consent Procedure
05/31/2011Informed Consent Procedure-Signed Copy
03/22/2004Informed Consent Process
02/29/2008Informed Consent Process
06/06/2011Informed Consent Process
05/15/2015Informed Consent Process
05/19/2015Informed Consent Process
03/25/2011Informed Consent Process - Study Personnel
10/18/2012Informed Consent Process Documentation
07/06/2009Informed Consent Process in FDA Regulated Trials
04/03/2007Informed Consent Query
12/10/2002informed consent question
03/05/2003Informed Consent Question
02/14/2006Informed Consent Question
03/15/2006Informed Consent Question
11/24/2006Informed Consent Question
11/08/2007Informed Consent Question
08/04/2009Informed Consent Question
02/22/2010Informed Consent Question
07/23/2010Informed consent question
04/20/2011Informed Consent Question
04/27/2011Informed Consent Question
02/27/2012Informed Consent Question
04/08/2013Informed Consent Question
07/09/2013Informed Consent Question
08/15/2013Informed Consent Question
09/26/2013Informed Consent Question
10/14/2013Informed Consent Question
08/10/2015Informed Consent Question
09/12/2015Informed Consent Question
09/17/2015Informed Consent Question
12/13/2013Informed Consent Question -- Signature of Subject
08/28/2006Informed Consent Question- Changes
03/21/2012Informed Consent Question and ClinicalTrials.gov
04/03/2002Informed Consent Questions
03/09/2015Informed Consent Questions
07/29/2009Informed Consent Regulations
10/28/2009Informed Consent Risks Section
03/25/2002Informed consents
11/14/2003Informed Consents
08/08/2013Informed Consents
07/19/2014Informed Consents - Expiration
09/09/2014Informed Consent Signature
07/10/2015Informed Consent Signature Requirement
11/13/2013Informed Consent Statement for Studies Registered on clinicaltrials.gov
04/13/2012Informed Consent Time of Sign-Off
03/09/2015Informed Consent Translations
12/13/2011Informed Consent Update
03/20/2006Informed Consent Waivers
02/15/2007Informing Patients of Changes in PIs
10/30/2011Infusion Nurses
08/11/2006Initial and Date Stamper Use
11/08/2012Initialing/Dating Source Documentation
12/15/2014Initial Investigational Drug Shipment
12/06/2010Initials on consent form
04/02/2003Initials on consent forms
02/17/2009Initiation Report Left at Investigator Site
01/05/2011Ink Color Question
08/17/2009In Need of Your Expertise
10/17/2003Inpatient Research Facility
08/23/2010Input on Research Involving Children
10/23/2012Inquire: Guidance for Institutional Review Boards
06/04/2015Inquire about using a Potential New Food Ingredient in Clinical Trials
06/06/2005Inquiry
12/21/2005Inquiry
07/06/2006Inquiry
07/31/2006Inquiry
06/10/2008An Inquiry
07/15/2009Inquiry
10/13/2009Inquiry
03/10/2010Inquiry
03/17/2010Inquiry
07/13/2010Inquiry
07/28/2010Inquiry
08/25/2010Inquiry
09/09/2010Inquiry
10/14/2010Inquiry
10/17/2010Inquiry
11/10/2010Inquiry
11/16/2010Inquiry
12/22/2010Inquiry
01/06/2011Inquiry
01/20/2011Inquiry
03/09/2011Inquiry
05/06/2011Inquiry
07/15/2011Inquiry
09/11/2013Inquiry
03/24/2014Inquiry
09/06/2011Inquiry - Co-Investigators
02/28/2011Inquiry-EKG recording
07/01/2003Inquiry - IND Safety Reports
10/15/2014Inquiry: Are there GCP Mandatory Regulations on...
05/06/2011Inquiry: Risk to Subject
02/24/2010Inquiry about Access to Medical Records by Monitors
02/05/2013Inquiry about Clinical Trial Site-regarding
10/22/2013Inquiry about GCP Inspections
02/14/2008Inquiry about GDEA
05/29/2015Inquiry about ICH- GCP Guideline
06/11/2014Inquiry about Pharmacovigilance Activities - Reg
12/22/2014Inquiry about Remote Inspection
01/28/2015Inquiry about Scanning Data
01/18/2011Inquiry Clinical Hold
03/08/2011Inquiry Concerning Storage of an Investigational Product
05/11/2011Inquiry DOA/1572
04/05/2013Inquiry Financial Disclosure- Are investors in a Privately-Held Company considered Sponsors
06/17/2004Inquiry from [Redacted]
10/04/2011Inquiry on Guidance Document [redacted]
11/05/2007Inquiry on IRB Composition
09/02/2008Inquiry on Quality System Requirements for IRBs
05/24/2005Inquiry Prep Site for Inspection
02/23/2012Inquiry regarding Clinicaltrials.gov Identifier: NCT01290341
12/23/2009Inquiry Regarding Collection and Reporting of SAEs to IRB
01/30/2013Inquiry Regarding Non-Human Subjects Research Determination for a Project Involving an OTC Monograph
04/13/2014Inquiry Regarding Regulations regarding Adult Stem Cell Transplantation in Humans
08/31/2005Inquiry regarding SAEs
06/22/2010Inquiry Regarding Shipping Nude Vials to a Site for a Clinical Trial
12/10/2012Inquiry regarding SOC Drugs Risks in Consent Forms
01/12/2010Inquiry Regarding SOP Templates and Forms for Clinical Research Site
01/26/2015Inquiry regarding Third Party Safety Reports
01/20/2010Inquiry Re Obtaining Informed Consent
07/25/2008Inquiry RE Subject Incarcerated (then released) Post Enrollment
10/14/2008Inquiry Study Data Archiving
01/19/2010Inquiry Trial Master File Essential Documents FDA
03/28/2012Inquiry via NIH/NLM
04/19/2007Inspection Classifications
02/20/2015Inspection Fees
09/16/2010Inspection History Databases
10/24/2002Inspection of a new site
05/20/2013Inspection Preparation at Clinical Investigator Site
04/06/2010Inspection Question
06/14/2010Inspection Question
09/16/2014Inspection Reports
10/27/2009Inspections CBER Website
05/24/2010Inspections CBER Website - Follow-up
02/19/2008Institutional Official Serving on the IRB
12/30/2005Institutional Responsibilities for Conduct of Research
06/06/2005Institutional Review Board - ICH Guideline (E6)
06/06/2005Institutional Review Board - ICH Guideline (E6) Dear
04/17/2014Institutional Review Board Protocol/Amendments/Informed Consent Form Signed Approval Letters
10/06/2010Institutional Review Board Questions
12/15/2010Institution Name Change
05/04/2007Institutions Engaged in Research
09/17/2009Instructions for 1571
03/10/2009Insurance Co-pay Coverage for Research Subjects
10/10/2007Insurance Requirements for Clinical Trials
03/05/2008Intent-to-Treat Population
01/31/2008Interactive Double Duty Data Entry
10/19/2004Interim Analysis Data
05/24/2007Internal Audit Monitoring of NIH Sponsored Trials
12/30/2010Internal Audits
05/29/2013Internal Audits
10/01/2008Internal Monitoring
04/29/2009International AE Reporting Requirements
09/25/2008International Clinical Trials Conference
04/25/2002International criteria
07/25/2011International Inspections - Warning Letters
08/24/2011International Law
07/01/2009International Sponsors and Requirements for ICH GCP
07/07/2006International Studies
09/24/2012International SUSAR
01/29/2004Internet Postings
01/29/2004Internet Postings
09/11/2013Interpretation for Reviewing Potential Study Subject Records
02/27/2008Interpretation of 21CFR312.57(c)
08/09/2005Interpretation of 56.114
03/10/2014Interpretation Question
05/05/2006Interpretation to 21CFR 312.30(b)
10/21/2003Interstate Shipment of IND Drug for Clinical Trials
09/05/2011Interventional and Non-Interventional Trials Definitions
09/24/2004Intrinsa patch
07/21/2012Invention
04/16/2011Inventory Control
08/04/2010Investigational Device Question
06/25/2002Investigational Drug Accountability
09/06/2007Investigational Drug Administration
10/21/2002Investigational Drug Compliance for Clinical Trials
04/29/2009Investigational Drug Expiry Date Extension - Labeling
09/06/2006Investigational Drug Labeling Re Expiration Date
10/24/2008Investigational Drug Policy Procedure
08/22/2006Investigational Drug Question
05/17/2006Investigational Drugs
07/31/2009Investigational Drugs Requiring Double Lock System
09/05/2007Investigational Drug Therapy
04/07/2003Investigational Pharmacist
01/22/2013Investigational Product
03/31/2012Investigational Product: Clinical Trials
02/22/2007Investigational Product Label Question
07/14/2006Investigational Product Management
11/25/2009Investigational Product Storage
08/07/2013Investigational Product Temperature Monitoring
01/29/2015Investigational Product Temperature Monitoring
02/13/2012Investigative Site Administrative Structure
11/04/2003Investigator
04/15/2005Investigator's Brochure
12/19/2011Investigator's Brochure for Device Trials
05/27/2011Investigator's Dating Documents
05/30/2012Investigator's Essential Documents to Be Kept Out of the Site
09/18/2009Investigator's Financial Disclosures and Clinical Trials
03/18/2008Investigator's Signature
10/18/2003Investigator's Signature on Consent
08/01/2012Investigator-Initiated Clinical Trials
04/12/2002Investigator-Initiated Research
05/04/2010Investigator-Initiated Study
07/12/2010Investigator - Observational Study
06/04/2009Investigator Agreements - Sub-Investigators
03/25/2011Investigator Brochure Guidance for Medical Devices
04/20/2005Investigator Brochures
09/26/2012Investigator Coverage
12/04/2008Investigator Discontinuation
01/01/2010Investigator filling in the 1572
04/13/2009Investigator GCP Training
10/13/2015Investigator GCP Training Online
10/13/2015Investigator GCP Training Online
08/24/2011Investigator Initiated IND Monitoring
08/06/2013Investigator Initiated IND Submission
04/16/2011Investigator Initiated Inquiry
10/14/2005Investigator initiated studies
07/21/2014Investigator Initiated Study
04/27/2015Investigator Initiated Study
08/30/2005Investigator Initiated Study Compliance
09/09/2011Investigator Initiated Trial
06/13/2002Investigator Initiated Trials
12/18/2008Investigator initiated trials
12/18/2008Investigator Initiated Trials
11/18/2009Investigator Leave of Absence
12/11/2009Investigator License Requirements
10/30/2006Investigator Listing Question
06/13/2011Investigator Meeting Expenses
11/17/2004Investigator Meetings
03/09/2005Investigator Meetings
02/01/2006Investigator Meetings
06/10/2011An Investigator Moved His Office
05/24/2007Investigator Name- 1572
12/05/2011Investigator Names on 1572
03/09/2009Investigator Non-Compliance
11/25/2009Investigator Oversight
11/25/2009Investigator Oversight
06/24/2011Investigator Oversight
06/26/2006Investigator Own IND Study
04/18/2008Investigator Payment Question
11/03/2009Investigator Qualifications
11/20/2007Investigator Record Retention
04/08/2010Investigator Records
01/20/2010Investigator Records in Event of Research Practice Closure
05/17/2010Investigator Recruiting
09/24/2010Investigator Reporting
03/10/2011Investigator Reports
08/17/2010Investigator Responsibilities-Appropriate Delegation of Tasks
12/08/2015Investigator Responsibilities/Delegation of Authority
05/05/2011Investigator Responsibilities Clarification
03/18/2008Investigator Responsibility Questions
02/08/2010Investigator Responsibility Specifically Detailed in Protocol
01/07/2015Investigator Reviewing and Signing eCRFs
03/19/2009Investigators Brochure
08/24/2012Investigator Signature on EKG
05/19/2009Investigator Signature on Financial Disclosure
01/24/2013Investigator Signature on IND Safety Reports
05/04/2005Investigator Signatures
03/26/2002Investigator Site control of source documents
04/03/2007Investigator Site Part 11 Question
07/23/2007Investigator Site SOPS
07/26/2010Investigator Site [Redacted] Certified Lab not being on the 1572 Form
01/23/2013Investigators Listed on ICF and 1572
10/23/2013Investigator Sponsored Research Query
12/22/2005Investigator Sponsored Trials
04/01/2009Investigator Sponsored Trials
03/02/2012Investigators Training
05/09/2012Investigator Submission of Protocol Deviations to IRB
02/24/2010Investigator supervisory responsibilities for sponsor field personnel.
10/13/2006Investigator Terminated
08/17/2009Investigator Un-Signing a 1572
09/04/2015Invitation to Participate in Biotechnology Workshop
12/10/2012Involving a Nurse Practitioner as Sub-Investigator in Clinical Trial
01/20/2010IP Label Question for Reduced Dose
01/20/2010IP Label Question for Reduced Dose
08/20/2003IRB
04/15/2005IRB
03/16/2007IRB
07/23/2007IRB
05/13/2009IRB
11/20/2012IRB
09/18/2013IRB
03/08/2010IRB's
03/24/2004IRB's Continuing Review
12/08/2006IRB-Approved Consent Form
07/24/2013IRB-IEC Membership
02/06/2009IRB-IND Approval Order Question
03/03/2005IRB/Ethics annual review
03/03/2005IRB/Ethics annual review
12/20/2010IRB/IEC
06/05/2007IRB/IND
12/09/2015IRB Acceptance of Final Sponsor Report
09/20/2005IRB activities
07/07/2015IRB Address Change
08/29/2007IRB Administrative Review
09/06/2015IRB and Continuing Review
09/09/2015IRB and Continuing Review
09/17/2004IRB and ICF Requirements
06/06/2002IRB and Informed Consent Regulations
06/16/2009IRB and Informed Consent Revisions Based on New Risk Information
02/28/2008IRB and Investigator Meeting
02/01/2006IRB and Medwatch Reports
07/31/2003IRB and Part 11 Compliance Question
12/07/2006IRB and Patient Registries
12/07/2006IRB and Suspensions
07/19/2007IRB Approval
03/13/2008IRB Approval
08/29/2008IRB Approval
10/11/2012IRB Approval
06/24/2013IRB Approval
04/07/2011IRB Approval and the Regulations
06/05/2007IRB Approval Before IND
03/19/2010IRB approval for written information to be provided to subjects
03/06/2006IRB Approval Letter
05/23/2008IRB Approval Letter Details
01/28/2004IRB approval notices
06/07/2012IRB Approval of Clinical Trials.gov
06/05/2014IRB approval of Dear Dr Letters
06/03/2002IRB approval of herbal products
03/30/2010IRB approval of Protocol
10/06/2003IRB approval of protocol amendment for extension study
04/23/2008IRB Approval of Study Ads
04/06/2009IRB Approval Question Compassionate Use
07/10/2009IRB Approval Required for Referral Sites
07/19/2002IRB approvals
03/04/2004IRB approval status
05/02/2007IRB Authority
11/26/2007IRB Authority
06/08/2009IRB Board Member Interpretations of SOP's
05/23/2008IRB Certification
01/23/2012IRB Chairman
04/30/2004IRB Chair Signature Stamps
05/19/2006IRB CI Wanting to Terminate Study
07/13/2012IRB Clarification Query
02/02/2006IRB Closing-Transfer
06/03/2012IRB Compliance
05/03/2012IRB Compliance Issues with Protocol Waiver of Jurisdiction/Accept Approval of Foreign IRB
08/17/2009IRB Compliance Manual
08/17/2009IRB Compliance Program Manual Not on FDA Internet
07/29/2009IRB Compliance Question
08/31/2005IRB composition and related procedures
04/20/2007IRB Conflict of Interest Quorum
08/07/2008IRB Conflicts
06/15/2004IRB Conflicts of Interest
08/07/2008IRB Conflicts Separation of Business and Ethics
01/09/2007IRB Continuing Review
12/10/2009IRB Continuing Review and Informed Consent Submission
02/06/2005IRB Continuing Review Question
01/26/2015IRB Convened meetings
04/21/2008IRB Coverage for Institutions
01/26/2009IRB Coverage Pertaining to Approved Studies
08/19/2008IRB Date Stamps On Documents
10/16/2014IRB Deferral Letter Inquiry
10/14/2010IRB Documentation of AE Reviews for Studies using the Same Investigational Drug
11/27/2006IRB Documentation Questions
05/09/2005IRB documents and email
03/02/2010IRB Doubt
04/08/2010IRB doubt
10/02/2014IRB Ethical Inquiry
09/25/2010IRB evaluation of the scientific merit of a proposed study
04/26/2012IRB Exempt
11/06/2008IRB Expedited Approval of New Clinical Investigators
02/01/2010IRB Expedited Review
10/27/2010IRB Full Committee Review Question on CITI Program
05/11/2011IRB FWA Confirmation
03/09/2012IRB GCP Question
01/17/2006IRB HIPPA Guidance
01/05/2007IRB IEC Role in Clinical Trials
03/17/2011IRB IND Verification Question
08/26/2008IRB Info & the 1572
04/30/2002IRB Information
04/30/2002IRB Information
08/18/2008IRB Information and the 1572
01/03/2011IRB Inquiry
09/22/2014IRB Inquiry
07/16/2002IRB Inspection Info
10/28/2009IRB Inspection in [Redacted]
11/15/2007IRB Inspection List
12/01/2014IRB involvement
08/09/2012IRB Jurisdiction
10/23/2007IRB Jurisdiction Question
04/21/2008IRB Lapse of Approval
10/18/2006IRB Meeting
06/30/2004IRB Meetings convened via Teleconference
02/04/2009IRB Member COI Question
12/04/2013IRB Member Lab Director Voting
07/31/2003IRB membership
11/08/2007IRB Membership
04/08/2013IRB Membership
04/14/2013IRB Membership
04/17/2013IRB Membership
09/08/2014IRB Membership
02/20/2007IRB Membership- GCP Compliance
11/08/2011IRB Membership - Non-scientist
12/04/2011IRB Membership - [Redacted] Affirms its Meeting is correctly constituted but Refused to Release Member Names
04/26/2004IRB Membership and Designation of Scientist/Non-Scientist
01/15/2015IRB Membership List Question
02/27/2007IRB Membership Question
09/16/2008IRB Membership Question
02/17/2011IRB Membership Rosters
01/05/2002IRB move
12/17/2013IRB Name Change
09/05/2007IRB of Non-FDA Devices
02/18/2010IRB of Record for a CRO
02/04/2014IRB Ongoing Review of Studies Closed except for Data Analysis
12/14/2007IRB Oval of Medical History Form- Is This Required
07/22/2011IRB Oversight of IVD Studies Using De-Identified Archived Specimens
05/20/2005IRB Panels, Reciprocity
06/03/2008IRB Panels and Part 11 Questions
02/11/2013IRB Periodic Safety Reporting
11/13/2007IRB Physical vs. P.O. Box Addresses
06/06/2011IRB Primary Reviewer System Question
02/01/2008IRB Procedure for Closing an IRB
10/28/2003IRB processes
06/27/2005IRB Processing Documentation
07/30/2013IRB Qualified Personnel
09/07/2004IRB question
04/29/2005IRB question
08/18/2005IRB question
10/21/2005IRB Question
04/25/2006IRB Question
11/13/2007IRB Question
05/21/2008IRB Question
07/07/2010IRB Question
07/09/2010IRB question
08/13/2010IRB Question
10/17/2012IRB Question
07/28/2014IRB Question
07/28/2014IRB Question
11/14/2014IRB Question
12/27/2006IRB Question 2
05/03/2012IRB Question about Written Material
12/15/2009IRB question for You from [Redacted]
03/24/2005IRB Questions
12/08/2006IRB Questions
02/10/2009IRB Questions
05/31/2013IRB Questions
02/22/2005IRB questions - non -inferiority
01/26/2015IRB Quorum
09/10/2013IRB Quorum 5 Members
05/25/2007IRB Quorum Definition
01/05/2007IRB Quorum Voting
08/30/2004IRB Record Keeping Requirements
05/27/2010IRB Record Retention
07/19/2010IRB Record Retention Question
01/11/2005IRB records
06/19/2009IRB Registration
02/10/2011IRB Registration
11/29/2011IRB Registration
11/02/2015IRB Registration
02/27/2013IRB Registration / FWA
09/23/2009IRB Registration and IRB Regulatory Compliance
07/22/2009IRB Registration Assistance
08/25/2009IRB Registration Effect on Active Studies
09/22/2009IRB Registration Foreign IRB IECs
06/18/2009IRB Registration for EX-US IRBs
08/25/2009IRB Registration for FDA
03/02/2006IRB Registration for Foreign Studies
09/23/2010IRB Registration Info Request
03/15/2010IRB Registration Information
08/27/2009IRB Registration Question
01/12/2012IRB Registration Question
08/11/2009IRB Registration Requirements
07/01/2009IRB Registration Rule
04/30/2007IRB Reporting
09/04/2013IRB Reporting Requirements for IND Exempt Studies
01/11/2010IRB Reporting to FDA, Follow Up from PRIM&R Presentation
05/21/2008IRB Reports to Institution
12/10/2007IRB Request for IND Information
08/29/2007IRB Request for Information on Promotional Materials
01/06/2003IRB requesting Budget for approval of study
12/30/2003IRB requesting Budget for approval of study
05/20/2013IRB Requests Copy of Patient Consent Signature Page
03/21/2013IRB Requirements for Site
07/23/2014IRB Research
07/23/2014IRB Research
03/16/2015IRB Responsibility for Disclosure of 21 CFR 50.25 C for Applicable Clinical Trials
07/17/2006IRB Responsibility for Phase IV studies
05/19/2003IRB review
09/13/2005IRB Review
09/13/2005IRB Review
10/05/2011IRB Review
06/04/2008IRB Review- Community Consultation- Public Disclosure Plans
09/29/2009IRB Review- Non-US Study
06/08/2012IRB Review and INDs
01/13/2015IRB Review Models
08/12/2009IRB Review of Advertisements
08/05/2008IRB Review Of AE Reports
09/18/2008IRB Review of AE Reports
08/21/2002IRB review of approved marketed products
04/11/2008IRB Review of cGMP Facilities
08/04/2008IRB Review of CRF
10/03/2003IRB review of final reports
09/04/2012IRB Review of Human Factors/Usability Testing
05/23/1015IRB Review of IND Exempt Studies
02/22/2008IRB Review of Medical Questionnaires
03/25/2013IRB Review of Non-Specific NIH Website Language
10/22/2015IRB Review of NSR Device
11/27/2005IRB Review of Phase IV Studies
11/29/2005IRB Review of Phase IV Studies
01/16/2003IRB review of protocol information
08/31/2010IRB Review of Research with an IND
06/29/2007IRB Review of Stand-Alone HIPAA Authorizations
06/11/2015IRB Review of Studies Requiring an IND
04/30/2007IRB Review of the FDA 1572
08/18/2005IRB Review of Written Info Given to Subjects
04/29/2011IRB Review Question
07/31/2014IRB Review Requirement for Non-Treatment Development Project
09/20/2012IRB Review versus Approval
07/13/2006IRB Roles
12/06/2011IRB Roster & IRB Compliance
10/28/2014IRB Roster Change
07/16/2004IRB Rosters
02/21/2007IRBs
07/18/2003IRBs' obligation to ensure that an investigator has obtained an IND
06/18/2009IRBs- Electronic Communications
06/02/2003IRBs and IECs
10/01/2009IRBs and Protocol Deviations
08/29/2008IRB Separation of Review
12/20/2012IRB Situation Question
03/14/2011IRB Study Approval
07/15/2003IRB subcommittee
01/30/2013IRB Submission Question
07/06/2009IRB Submitted Study
04/07/2005IRBs versus IECs
12/02/2004IRB Violation?
02/07/2005IRB Waiver
02/04/2007IRB Waiver of Jurisdiction
06/02/2015IRB Waiving Jurisdiction
06/03/2002IRB Winding Up
01/10/2007IRB Withdrawal of Approval
09/02/2008Is 1572 a Legal Contract
08/15/2007Is 1572 Mandatory in Non-US Trial
05/04/2009Is 1572 Necessary For Sub Study
01/03/2007Is an IND Required if There is No Interstate Commerce Involved
01/30/2014Is a PI e-Signature Required on Electronic ClinRO Records?
07/09/2007Is Fasting Prior to Consent a Research-Related Activity
01/19/2007Is Fasting Prior to Signing the ICF a Research Activity
06/30/2011Is FDA Approval Required?
11/19/2013Is Form FDA 1572 Required?
07/22/2002Is GCP a Law?
09/30/2010Is GCP the Law?
03/05/2008Is ICD for Subjects or Sponsors
09/10/2010Is ICH/E6 a Requirement for IRBs? Hot topic!
04/25/2013Is IND Needed for Study of 2 Approved Drugs being used in Combination?
03/02/2012Is IND Required for Generics Studies Intended for European Submission?
03/05/2008Is One Study Enough
04/07/2014Is Pregnant Partner a Research Subject?
10/23/2013Is Registration of Expanded Access IND study on ClinicalTrials.gov required?
04/29/2011Is Subject Initial Considered as Confidential Information?
01/31/2012The Issue of Citizen
03/10/2012The Issue of Citizen
02/16/2013Is this a FOIA request?
09/01/2010Is this an FDA Regulated Clinical Trial?
04/21/2009Is This IVD Research?
01/27/2010Is this legal?
05/22/2014Is this Study FDA-Regulated?
10/03/2010IT SOP
10/31/2012IVD - Financial Disclosure Question
10/31/2012IVD - Financial Disclosure Question
09/02/2008IVD Device Study and Informed Consent
01/27/2004IV mucomyst & Hydroxyprogesterone - medical Rx - IRB/IND needed?
02/08/2013I was Curious what the Standard Definition of a Clinical Trial is
10/21/2014IWRS as Unblinding Mechanism
04/22/2010Jan 2009 Guidance on Reporting of Unanticipated Problems to Irbs
03/09/2006JCAHO Accreditation
10/05/2007Job Descriptions
03/03/2010Just a Quick Question on Form 1571
09/22/2011Keeping Scanned Copies of Consent Forms
08/11/2010Kind Ask
12/21/2005Kind Atten: Bonnie M. Lee
12/28/2009Kindly Resolve This Case That Will Help Me
03/26/2009Lab Abnormalities
07/19/2011Lab AE
06/16/2003Lab certification and 1572s
03/28/2007Lab Change of Address
11/08/2011Lab director CV and Med License - Are These Really Essential Documents
01/12/2009Lab Document Retention
01/08/2014Lab Drawing Stations
04/25/2006Labeling Donor Tissues
11/21/2007Labeling for Commercial Drugs Tested at New Dose
04/03/2003Labeling Investigational drug for FDA-regulated clinical trial
09/03/2003Labeling investigational drugs
11/09/2012Labeling of Clinical Trials Specimens
12/16/2008Labeling of Drugs- IND- Exempt Study
05/21/2014Labeling of IMPs for BE studies
10/14/2009Labeling of Investigational New Drug
11/20/2012Labeling of Investigational Products
06/21/2011Labeling of Source Documents and Subject Identifiers
12/04/2008Labeling Placebos
11/12/2002Labeling Requirements
07/25/2008Labeling Requirements for Clinical Trial Drugs
11/13/2012Labeling Requirements of Non-IP
04/24/2015Labels for Investigational Products
02/06/2007Laboratories Used for Clinical Trials
05/06/2008Laboratories Used in Clinical Trials
12/12/2011Laboratory
07/21/2009Laboratory Accreditation
02/12/2008Laboratory Certificate
04/21/2015Laboratory Certification
02/05/2013Laboratory Certifications
03/24/2009Laboratory Certification with Protocol Amendments
11/20/2007Laboratory Director's CV
05/01/2007Laboratory Director CVs
12/30/2011Laboratory document requirements
02/03/2010Laboratory Practices
11/28/2006Laboratory Records
05/30/2008Laboratory Reference Ranges
11/07/2002Laboratory Reports
09/18/2007Laboratory Report Signature Question
08/10/2012Laboratory Requirement for a Study under an IND
02/08/2008Laboratory Values in Clinical Research
07/08/2010Lab Reference Ranges & EDC
02/01/2012Lab Results and AEs
03/06/2006Labs Listed on Form 1572
10/03/2012Labs on 1572 - Used only Once
02/26/2007Labs that Are Included on the 1572
01/29/2009Lack of Continuing Review Due to Administrative Error
08/08/2008Lack of Documentation of Informed Consenting
08/09/2006Lack of Medical History in Clinical Trials
11/21/2013Language Barriers
05/31/2012Language in Clinical Trial Agreement regarding Sponsor approving Sites Audit Response
06/15/2010Lapse between Approval and Receipt of a Consent
04/04/2007Lapse Between Expiration and IRB Renewal
04/03/2007Lapse of IRB Approval
02/24/2014LAR (Legal Authorized Representative) Query
04/21/2006LAR Signature Line
09/05/2012LAR with Informed Consents
02/20/2003Last minute question
03/28/2012Last Progress Note
09/21/2010Late Reporting of SAEs
04/25/2013Latest change in ICH GCP guidelines
04/25/2013Latest Change in ICH GCP Guidelines
04/03/2007Leftover or Returned Study Medication
01/28/2003Legal Ages
07/21/2008Legal Competency vs Decisional Capacity
06/02/2014Legality, Validity and Compliance of Electronic Signatures
08/30/2012Legally Acceptable Representative for Adolescent Subject
08/31/2010Legislative Control on Clinical Trials and Compliance with GCP
08/02/2012Length of Investigator's Brochure
03/03/2006Length of Time to Archive Study Data
08/23/2011Letter of Objections
08/19/2004Letter Regarding Financial disclosure form
12/30/2008Letter Sent to OHRP- Now Forwarded to OGCP- Pt. Safety and HIPPA Violations
06/05/2013Levothyroxine
02/03/2012Liability Question
11/04/2005Life Threatening SAE
08/28/2003Limitations on funding of investigator initiated research proposals
12/05/2010Limits of IRB
04/09/2008Lines in CRFs
05/14/2004Link
06/10/2004Link
02/09/2005Link
10/16/2009Link
06/16/2010Link-Whether IND-IDE Needed
10/16/2009Links
06/09/2006Links to Financial Disclosure Regulations Guidance Documents
03/12/2003Links to websites
06/25/2007Link to Draft Guidance on Emergency Research Studies
06/25/2007Link to Draft Guidance on Emergency Research Studies
01/07/2009Link to Notice Withdrawing ANPRM
05/17/2005Link to OHRP HSP Training
03/19/2010Link to replies to previous queries
04/13/2004Link to the Guidance for Studies Conducted Under 21 CFR 50.24
06/25/2007Link to Webpage
10/16/2008Listing 2 IRBs on 1572
03/02/2004Listing IRB Assurance on FDA Form 1572
04/16/2002Listing National Ethics Committees on FDA-1572
04/20/2010Listing of clinical trial information on private websites
11/26/2003Listing of FDA sanctioned resources
02/22/2005Listing of Investigators Conducting Clinical Research
02/06/2009Listing Pharmacist In Block6- 1572
09/01/2010Listing Subinvestigators on 1572
03/24/2010List of 483
02/02/2005List of 5024 Studies
06/17/2010List of Approved Trial Sites
11/13/2007List of Elements to Include in a Clinical Quality Plan
09/15/2008List Of Firms Who Have Been Fined
04/15/2010List of GCP
11/16/2009List of GCP Questions and Answers
05/28/2009List of IRB's in [Redacted]
02/25/2015List of Members Attending EC Meetings
07/29/2008Lists of DQ Investigators
08/17/2011Local Country Requirements vs. FDA Citation
11/23/2011Local Institutional Approval
07/23/2007Local Lab Listing on 1572
07/19/2011Location
03/19/2010Location of Proposed Regulation Changes
07/31/2006Logos for Clinical Trials
05/03/2007logs again
02/09/2011Long-Term Follow-Up Question
09/25/2007Long Term Follow-Up of Subjects in Closed Clinical Trial
02/17/2006Long Term Storage of Medical Information-Source Documentation
03/27/2007Long Term Study Subject Survival Follow-Up
02/05/2009Looking for an In-State GCP Course
05/18/2010Looking for Answer
07/23/2003Looking for a site
04/15/2010Looking for Clarification
10/26/2010Looking for Information Sheet
03/26/2007Loss of E-Data
01/16/2014Lost Original Consent but have a Copy
02/27/2013Lost Source Documentation (Medical Chart)
09/01/2011Lost to Follow-up and PDF Documents
01/22/2015Mailing/Emailing Consents
09/06/2011Mailing Consent Form
05/07/2008Mailing of Study Investigational Drug to a subject...
09/04/2007Mailing Re-Supply of Study Drug
05/16/2013Maintaining Annual IRB Approvals for FDA Protocol
01/08/2004Maintaining Certification
09/24/2013Maintaining Data Timelines
02/28/2006Maintaining Records When No Subjects Are Enrolled
08/20/2012Maintaining Regulatory Documents for Auditing
06/07/2005Maintaining Rough Copies
11/26/2002Maintaining the Blind
11/20/2007Maintenance of Images
12/14/2005Maintenance of Records at Trial Site
07/12/2010Maintenance of Study Records in Paper Form
08/23/2006Maintenance of Training Documentation for Computer Systems
12/11/2015Making Corrections
12/11/2015Making Corrections
04/28/2008Making Corrections in Documents
11/12/2003Management of Study Medications
03/06/2015Mandatory Banking for Future Unspecified Research
02/15/2012Mandatory Reporting
10/08/2002Manufacture of GCP drugs
05/02/2014Market Research during Clinical Trial Phase
06/12/2014Master Personnel Lists
01/27/2005Masters
01/13/2005Maximum Percentage of Patient Data Acceptable to FDA
09/23/2010May 2010 1572 Guidance
12/03/2008May a Sponsor Sue Email to Notify FDA of Fatal or Life-Threatening Adverse Events
01/12/2006May Site Staff Participate in Study
11/08/2011May we rely on the HR Credentialing Office to obtain/maintain proof of current and ongoing licensure/registration for investigators?
03/22/2012MBA Student looking for Information regarding GXP Auditing
09/02/2015MD vs. APN Investigators
06/19/2003MD vs nonMD as PI
04/11/2005Meaning of All Participating Investigators
01/20/2015Measurements on PROs
06/28/2007Med Care for Subjects
02/08/2008Media Release from Sponsor
02/08/2008Media Release from Sponsor
02/08/2008Media Release from Sponsor
03/07/2012Medical Device/IVD Clinical Trials using Foreign Sites
04/10/2006Medical Device Approval Advice Needed
01/09/2012Medical Device GCP AE/MDR Question
08/30/2007Medical Device Question
04/03/2008Medical Device Research
04/05/2011Medical Devices
06/14/2012Medical Device Trials: FDA 1572 + Financial Disclosure versus Investigator Agreement
05/17/2007Medical Files of Subjects
09/07/2007Medical History Collection
07/24/2009Medical History in Clinical Trials
07/24/2009Medical History in Clinical Trials
03/11/2013Medical History Records & Drug Accountability
06/29/2007Medical History to Determine Eligibility
08/11/2008Medical History Verification
10/03/2002Medical License?
05/24/2007Medical License Question
04/23/2003Medical Malpractice
05/11/2003Medical Monitor
06/22/2006Medical Monitor
06/23/2014Medical Monitor/Medical Expertise - Qualification Requirement
12/04/2013Medical Monitor in a Clinical Trail
04/26/2006Medical Monitoring and Degreed Personnel
02/06/2013Medical Monitor Q
10/10/2008Medical Monitor Qualification Questions
02/23/2004Medical Monitor Question
02/23/2004Medical Monitor Question
02/04/2008Medical Monitors
01/24/2003Medical Monitors and Conflict of Interest
11/07/2002Medical Records
11/20/2007Medical Records
03/05/2008Medical Records
11/08/2011Medical Records
02/28/2008Medical Record Screening
02/28/2008Medical Record Screening
10/05/2011Medical Records Request
12/02/2011Medical Records Translation
11/15/2007Medical Records vs. Medical History
04/25/2012Medical Safety Monitor
09/17/2004Medical Screening Period
09/02/2005Medical Waivers During Clinical Trials
03/23/2011Medication Administration
02/24/2009Medication Changes and Testing Prior to Screening
03/25/2011Medication Safety Issue-Investigational Drugs
07/01/2010Medication Usage
09/15/2010Medicinal Test (or Pre-Clinical Trial) in Animal
03/06/2008MedWatch Reporting
05/29/2014Meeting Minutes
11/04/2004Meeting Questions
01/24/2008Meetings With CIs
04/30/2008Member Conflict
08/31/2005Membership on IRB
08/13/2009Memory Aids
03/10/2008Memos to File
01/11/2008Message
03/08/2010Message for [Redacted]
09/03/2015Message from Unknown sender [Redacted] - Investigator Record Retention
06/24/2008Meta-Analysis Guidelines
09/15/2010Method of IRB Approval/Question What Constitutes FB Approval
09/27/2002Microfilming Study Records
07/03/2013Microsort Clinical Trial
11/17/2010Minimal risk non-drug non-device dissertation question
04/29/2008Minimum info on screened subjects
04/29/2008Minimum Info on Screened Subjects
07/25/2007Minimum Requirements for CRC
02/08/2010Misbranding in Clinical Trials
09/04/2007Missed Informed Consent Question
09/23/2011Missed Screening Activity
03/08/2007Missing Data
08/20/2008Missing Followup Letter
09/13/2012Missing Subject Source Charts
05/21/2010Missing Unbilnding Envelope
12/27/2012Mission is taking Flight
07/25/2003Mistake in Clinical Trial
01/30/2014Mobile Chemotherapy
08/19/2013Modified 50.25 c Language
03/15/2006Monetary Payments to Clinical Investigators
11/21/2006Monitor-Subject Contract
12/04/2015Monitor Area for Record Review
04/11/2014Monitor Assistance with Completing Study Tracking Logs
05/02/2014Monitor Assistance with Completing Study Tracking Logs
05/30/2008Monitoring
11/06/2013Monitoring, Auditing and Reviewing of Clinical Trials
10/30/2008Monitoring by Sponsors
08/01/2006Monitoring Compliance Questions
05/12/2011Monitoring Guidance Document
08/08/2011Monitoring Informed Consent Forms
09/21/2011Monitoring Investigators in Clinical Trials
10/30/2014Monitoring IP Storage Temperature
09/08/2013Monitoring manual
03/14/2013Monitoring of Clinical Investigators, Guideline for the, Guidance for Industry
03/07/2006Monitoring of Phase 1 Studies
04/21/2003Monitoring reports
07/03/2011Monitoring Reports
06/26/2013Monitoring Requirements for Post-Marketing Studies - Minimum Requirements
06/25/2004Monitoring Visit F/Up Letters
06/03/2011Monitoring Visit Log in Clinical Trial
12/02/2009Monitoring Visit Question
06/03/2010Monitor Interpreting Data
11/06/2007Monitor Training
07/07/2006Monitor Training Records
02/23/2009Monitor Witnessing Study Procedures
06/21/2006Monitory Directly Contacting Subject
08/22/2011More Information
02/20/2003More Questions
04/14/2011Most Recent 1572
04/19/2011Most Recent 1572 Form
09/16/2010MOU re Brazil GCP Inspections
08/04/2015Moving to eTMF - Request for Guidance on 1572 Originals
05/31/2013MRI Technician Qualifications
04/11/2002ms
03/06/2014MS Word Document as Source
02/21/2008Multinational Trials and 1572s
02/19/2004Multiple 1572 Questions
03/23/2004Multiple 1572s for the same study
05/11/2015Multiple Contracted IRB's/Protocol
05/12/2015Multiple Contracted IRB's/Protocol
10/28/2009Multiple IRBs- FDA1572
04/03/2015Multiple Questions
07/09/2014Multiple Site Delegation Logs?
05/19/2008Multisite Studies and Principal Investigators
05/28/2014Multi Specialty Group of Physicians
12/23/2003Must a Form FDA 1572 be Used?
03/26/2008Must ICD Contain Fin Disc Info
10/06/2008Must NonUS Protocol Differ From US Protocol
10/14/2008Must Payments to Subjects Be Reported to IRS
07/24/2008Must Subject's Medical Records be Obtained
12/29/2008My GCP Question
04/06/2010My Health
06/08/2006My Monitors Contact Subjects
02/08/2010Name disclosure on Informed consent document question
11/19/2002Named person
02/15/2011Narratives for Adverse Dropouts in the CSR
09/27/2013NCI Website References in Consents
08/13/2008NCT Identifier
10/27/2015NCT Locations
10/22/2008Necessary Qualifications
03/25/2005Necessity to Notify Investigators of SAEs
01/18/2011Need Clarification and Guidance
07/27/2005Need Clarification of ICH Guideline 8.3.14
04/04/2013Need Confirmation
11/24/2009Need for 1572- 2nd Protocol
07/22/2005Need for a Data Safety Monitoring Board
07/14/2009Need for GCP Certification
10/21/2008Need for IND and IDE
03/26/2010Need for IRB Reapproval for Drug Coming Off Hold Status-Redacted
10/22/2008Need for Subjects Medical Records
04/07/2008Need GCP Materials
12/21/2005Need Guidance/Advice on Developing a Web-Based Consent Document
06/25/2002Need info
03/23/2010Need Information
08/30/2010Need Information
02/01/2012Need Opinion
11/13/2003Need some knowledge
05/10/2002Need the GCP
03/29/2010Need your Kind Opinion
01/19/2011Need your Kind Opinion
10/13/2006Need Your Opinion
01/21/2012Need Your Opinion
01/11/2011Network Trial 1572
04/11/2013New 1572 Form
04/19/2013New 1572 Form
05/02/2012New 1572 Form dated 2/12
09/08/2013New 1572 Template versus Former 2 Page Format
06/05/2012New CI
04/09/2002New drug application process
04/23/2013New Electronic Version of the 1572 with Glitches - Can a Sponsor Still Use the Older pdf Version
09/07/2012New FDA1572
07/25/2012New FDA 1572 Form
12/21/2011New FDA Rules for Clinical Investigator Compliance
09/27/2012New Format for 1572
08/26/2002New GCPs
03/09/2012New Informed Consent Requirements, 21 CFR § 50.25(C) - Query
10/24/2006New Part 11 Re-Write
07/01/2008New Policy for Adverse Events and Unanticipated Problems
12/21/2011New Required Informed Consent Language
11/30/2007New Research Model
04/15/2011New Research Site. CRC with Some Questions
10/25/2006New Safety Information Question
01/09/2007News Articles Versus Advertisements for Recruitment
05/13/2010New Side-Effects Detection System - Question
06/10/2005Newsletter
06/23/2003New Trial Question
08/05/2010New Version of the 1572 Available on the ctep.cancer.gov Website?
08/05/2010New Version of the 1572 Available on the ctep.cancer.gov Website?
11/10/2009Nicotine Vaccine
11/24/2015NIH HSP Training
07/16/2003NIH INDs
10/27/2004NIH Regulation
12/19/2006NIH Sponsored Trials
02/22/2005Non-Clinical Personnel Site Visits
04/09/2009Non-Compliance Questions
06/26/2012Non-Conflicting Studies
08/20/2003Non-English consents
01/22/2010Non-English Speaking Patients
11/05/2012Non-English Speaking Subject at a Foreign Site
08/13/2012Non-GCP Compliant Data Questions
09/10/2007Non-IND Medwatch Form
07/16/2010Non-IND Record Retention
06/28/2011Non-licensed Principal Investigators
10/01/2007Non-Licensed Study Personnel
10/25/2006Non-Physician Investigators
05/30/2013Non-Scientist Definition
06/15/2005Non-study SOP Deviations
02/06/2009Non-US Investigators- FDA 1572 Form
05/19/2012Non-US Investigators conducting INDs
12/30/2008Non-US IRB
02/06/2009Non-US Sites and FDA 1572 Form
06/28/2012Nonclinical Lab Study
04/22/2010Non Compliance by Patient as Protocol Deviation
10/18/2010Noncompliance Issue/Reportable
06/19/2009Nondiscrimination-Civil Rights Laws Apply to Subject Clinical Studies
01/19/2010Non Face to Face IC Process
10/29/2007Non MDs as Clinical Investigators
10/22/2004Non NIH-Funded COC Applicants
04/18/2006Non US Studies
06/25/2010No Response Present
04/21/2015No Safety Net for Humans in Clinical Trials
11/30/2006No subject
08/22/2013No Subject
07/26/2010Notes to File
03/21/2005Notice of meeting regarding IRBs and adverse event reporting
10/22/2014Notification of Protocol Deviations to FDA
03/14/2007Notification of Suspect Serious Unexpected Adverse Reactions Time Lines to Investigators
04/01/2011Notification Regarding an IND
03/04/2008Notification Re Termination of a Study
11/18/2003Notification to FDA
10/25/2012Notification to Primary Care Physician
09/04/2008Notifying FDA About CI Noncompliance
05/08/2012Notify of Study Termination
03/29/2005No title.
08/22/2006November Workshop
06/03/2015NSR/SR Designation
08/26/2013NSR Determinations
04/22/2009Numbering Pages -Blanks In Records
06/19/2009Number of 1572s to Sign
10/08/2015Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 And 2015
11/03/2015Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 and 2015
11/05/2015Number of IRB, CI & Sponsor Inspections in Calendar Year 2014 And 2015
12/06/2011Number of Phase I Trials
09/20/2004Number of trials per C.R.A
02/01/2010Numbers of Approved Clinical Trials
02/01/2010Numbers of Approved Clinical Trials
02/24/2014Nurse Practitioner in FDA 1572
12/18/2007Nurse Practitioner Role in Clinical Research
12/13/2013Nurse Practitioners
01/28/2009Nurse Practitioners as Clinical Investigators
04/06/2009Nurse Practitioners as Sub Investigators
09/22/2010Nurse Practitioners Role in Clinical Trials
01/31/2014Nurses/Non-Nurses Distributing Study Drug
03/05/2013OAI and IRB review
12/21/2005Observational Studies
02/12/2008Observational Study 1572
12/30/2009Obtaining Medical Records for Participants in Clinical Trial
11/17/2008Obtaining Medical Records for Subjects in Research Studies
07/24/2008Obtaining Subject's Medical Records
04/25/2006Obtaining Subjects Files
08/13/2009Obtaining Urine Samples for Biomarker Study
11/02/2002Off-label use
07/14/2008Off-Label Use Being Marketed Being Used in Scalable Treatment Protocols by Affiliated Medical Practices
09/11/2012Off-Label Use of HUDs
11/23/2005Off-label use question
09/03/2013Off-Site Backup
04/13/2009Off-Site Record Storage
05/19/2004Off-Site SAE Review for Multicenter Trials
05/21/2004Off-Site SAE Review for Multicenter Trials (2)
11/12/2010Office of Good Clinical Practice
02/20/2015Official Identification for Clinical Subjects
01/22/2010Offsite Storage
03/22/2010OGCP work
10/14/2005OHRP's New Guidance Document on AE/Unanticipated Problems Reporting
10/05/2008OHRP Guidance vs. FDA Guidance
05/19/2005OHRP vs. FDA GCP guidelines
06/07/2005OHRP vs. FDA GCP guidelines
06/27/2013Omnibus Rule
10/10/2012On-Site Training on GCP
11/04/2011Oncology Trial
10/21/2009One More Question Re Financial Disclosure
12/08/2009One or More IRBs
08/23/2012Online 1572 Form
04/09/2012On Line Class on GCP
04/11/2002Online courses on GCP?
04/29/2009Online GCP Course
03/15/2012Online GCP Course
01/29/2013Online GCP training
02/04/2014Online GCP Training?
10/10/2007Online GCP Training for New Principal Investigators and Staff
06/24/2010Online Training
12/30/2011Online Training
01/26/2015Online Training
01/24/2011Online Training for PIs
05/21/2008Only One Study Required for Substantial Evidence
09/25/2015Onset Time for Recording of Adverse Events in Clinical Studies of an Investigational Product
09/16/2014On Site GCP Training
08/22/2012Onsite IRB vs. IRB of Record for a Study
09/18/2012On Site Pregnancy Testing
10/26/2010Open Label Extension and Blind Protection
02/08/2008Open Label Studies
10/05/2004Open Label Studies to Measure Patient-Reported Outcomes
09/25/2008Open Studies
04/14/2015Operational Accidental Unblinding
04/14/2015Operational Accidental Unblinding
12/23/2008Opt-In, Opt-Out Options in Informed Consent Documents
08/13/2015Optional Informed Consent Signature
08/14/2014Optional Procedures in a Clinical Trial
05/06/2008Oral Orders To Administer Test Article
04/24/2013Organ Donation.
12/06/2011Original Document of IRB Approvals, Kept at Site or at Sponsor
05/15/2014Original Documents for IND Submission
05/14/2010Original Informed Consent Document
03/27/2013Original or Scanned Documents
06/17/2009Original Record(s) Custody
05/29/2013Original Records
05/09/2008Original Scanfilms to be Obtained by Study Site
05/19/2009Original Signature on Form 1571
02/15/2011Original Signatures vs Scanned Signatures
01/23/2014Original Signature Vs Scanned Signature on Study Document
09/22/2008Originals of Scanned Documents
08/11/2006Original Versus Copy of Study Documents
04/01/2009Orthopedic Devices for Hips and Knees
03/10/2014OSI Reports Previous Years
03/01/2007OTC Switch Studies and GCP
09/13/2010Other Manufacturer Notification of Serious Adverse Events
03/11/2009OUS Clinical Trials
10/23/2009Out-of-Window Visit Calculations
04/13/2005Outdated 1572 form
05/08/2009Outside Agency Following Up with Subjects
05/14/2009Outside Agency to Follow Up with Subjects
10/31/2006Outside Laboratories
10/31/2006Outside Laboratory Documentation
11/29/2012Outsourcing Services
04/19/2011Over-Enrolled Subject Data Use
10/01/2008Overnight Stays Involving Human Subjects
03/25/2002Overseas GCP
03/10/2015Oversight of IRB Submissions
05/29/2013Oversight of Sponsor vs CROs
06/14/2013Oversight of Sponsor vs CROs
04/25/2007Oversite of Satellite Clinical Sites
03/20/2013Packaging and Adherence Information
03/20/2013Packaging and Adherence Information
05/09/2006PAHO Good Clinical Practices Document of the Americas
04/11/2013Paper Source Documents to Electronic
03/28/2013Paper to EHR
02/20/2008Paper Versus Paperless System
11/29/2005Parallel track drugs
11/29/2005Parallel track drugs
12/13/2004Parental Permission and Possible Waiver for Use of [Redacted]
11/24/2009Parent Who is Minor Consenting for Child
06/26/2003Part 11
05/08/2015Part 11 and Sponsor-Investigator Trials
04/01/2004Part 11 Compliance-Electronic Records, Electronic Signatures
02/16/2005Part 11 Compliance of open systems
02/02/2007Part 11 GCP Question Electronic Signature
02/02/2007Part 11 Issues IEC Communications
03/09/2006Part 11 Question
01/08/2007Part 11 Question Audit Trails
06/25/2002Part 11, and GCP guidance
02/09/2009Partial Withdrawal
06/09/2015Participants in Investigational Drug Studies
10/28/2009Participating in Clinical Trials
11/29/2013Participation in a Clinical Trial of Investigator's Relatives
08/26/2009Participation in Clinical Trial of Non-English Speaking Person
05/28/2014Participation in more than One Trial
06/21/2008Participation in Multiple Studies
12/10/2008Participation in Multiple Studies
07/31/2007Participation Of Relatives or Staff in Trials
01/28/2013Part time investigators and Form 1572
10/26/2010Patient / Investigator Access to Study Data for Post Study Treatment
06/19/2009Patient Being Denied Entry Into IND-1
01/23/2008Patient Clinical Samples and Retention
06/19/2007Patient Compensation and Injury
06/21/2002Patient Compliance Programs and FDA Approval
06/29/2007Patient Consent- Pregnancy Data Collection
04/30/2003Patient Consent Form
09/24/2012Patient Contact Information (Telephone) on ICF
07/12/2011Patient De-Identification
07/29/2011Patient Diary Entry Question/Clarification
11/24/2010Patient Enrolled in Two Clinical Trials Concurrently
03/05/2007Patient Identifier Question
03/27/2007Patient Information
09/23/2002Patient Informed Consent
08/22/2011Patient Questionnaires
09/11/2012Patient Reach Out Program
01/04/2005Patient Record Privacy Requirements
06/02/2009Patient Records
05/27/2009Patient Recruitment
11/21/2012Patient Recruitment for Clinical Trials in Developing Countries
11/18/2005Patient Recruitment Question
08/21/2008Patient Research Chart and Protocol
09/05/2003Patient responsibility
04/07/2006Patient Retention Campaign on a Long-Term Study
07/06/2010Patient Safety and Well Being for the Subject in Clinical Trials
11/09/2014Patient Safety Assessment
03/03/2003Patient screening logs
04/25/2008Patients Developing Dementia
07/12/2012Patient Specimen Retention
09/07/2004Patient Withdrawal
07/13/2007Paying for Study Drug
06/25/2007Payment- Subject Referrals
11/27/2007Payment for Time and Office Visit of Study Participants
04/10/2008Payment From Subjects
07/24/2003Payment of clinical trials subjects
10/15/2007Payments and Speaking Fees
10/22/2008Payments for PI Meetings
08/14/2008Payments from Pharm Cos
03/27/2008Payments to Clinical Investigators and Their Staff
09/03/2002Payments to Principal Investigators (PIs) and Site Management Organizations (SMOs)
07/10/2006Payments to Subjects
04/16/2007Payments to Subjects
06/11/2008Payments to Subjects
06/04/2013PDF Versions of ICH/GCP, ISO 14155
11/07/2007Pediatric Blood Draws
04/17/2003Pediatric Clinical Trials
02/24/2015Pediatrician Required for Subjects of 16- 17 Yrs Age
06/27/2007Pediatric Research
02/04/2007Pediatrics Pregnancy Question
10/25/2011Pediatric Trial
12/01/2008Pediatric Vaccine Trials vs. Drug Studies - Reg Requirements
10/29/2009Peramivir IV Use
04/17/2008Permission from Sponsor
05/28/2002Permission to use information in a local publication
01/25/2008Personal Databases
06/21/2011Personal Laptop Use for Source Document Generation
02/19/2004PERU
07/13/2009Pharmaceutical Communication With Sponsors
09/22/2014Pharmaceutical Company Requirements for Licensed MDs
09/22/2014Pharmaceutical Company Requirements for Licensed MDs
09/22/2014Pharmaceutical Company Requirements for Licensed Mds 2 and 3
07/07/2009Pharmaceutical Sponsor Payments to Principal Investigators
09/09/2002Pharmacist on the IRB Committee
02/04/2008Pharmacists
06/27/2005Pharmacists and Conflicts of Interest
12/02/2013Pharmacogenomics Research and Promoting its Clinical Research-Financial Arrangements
11/27/2012Pharmacokinetic Sub Study Informed Consent
07/07/2014Pharmacy and Laboratory Temperatures
05/09/2008Pharmacy Role in Clinical Trials
04/12/2010Pharma Industry Discussion Regarding Digital Versus Electronic Signatures
02/04/2008Pharm Comp Question
02/16/2007Phase 1 Research Projects
06/24/2008Phase 1 Studies
09/05/2013Phase 1 Studies conducted outside of US
08/25/2013Phase 1 Study for a Pediatric Drug
07/20/2010Phase 1 Trial Requirements
09/29/2008Phase 3 Trials For Hep C
01/20/2006Phase 3b and 4 Monitoring
08/22/2006Phase 4
07/17/2012Phase 4
08/22/2006Phase 4 Studies
01/21/2010Phase 4 Studies
08/28/2006Phase 4 Studies (FU)
11/25/2002Phase 5 studies.
05/10/2005Phase I Clinical Trials
10/13/2009Phase I Clinical Trial Units In [Redacted]
02/18/2009Phase II and III Clinical Trials
09/27/2012Phase IIa vs. IIb Clinical Trials
01/30/2014Phase III Clinical Trial - Enrollment Question
09/20/2012Phase III Clinical Trials
09/23/2012Phase III Clinical Trials
10/04/2007Phase III Study
08/14/2010Phase I Research Facilities
11/01/2012Phase I Screening Consent
07/01/2015Phase I Study, ClinicalTrials.gov ICF Language
05/14/2003Phase I trials
08/31/2005Phase IV clinical trials
07/29/2005Phase IV Studies
08/01/2005Phase IV Studies
02/17/2011Phase IV Studies
09/25/2008Phase IV Study Protocol on Previous Studies
03/27/2007Phase IV Surveillance
05/09/2008Phase of Clinical Trials
03/05/2007Phase One
11/26/2013Phase One Question
04/22/2009Phase One Units
11/30/2009Phases of a Clinical Trial
05/07/2008PhD Clinical Investigators
02/18/2013PHI and Study Records
06/11/2015PHI Entered into EDC
07/12/2003Phlebotomy in Clinical Investigations
06/26/2008Phone Call Consent
01/09/2015Photo ID and Screening
03/24/2008Photos Of Subjects
01/20/2011Physical Assessments
04/30/2010Physical Disposition of a Ds office
08/29/2014Physician-Investigator Dual Role
10/18/2007Physician Assistants
12/08/2009Physician Enrollment
04/24/2010Physician Involvement in Clinical Trials Question
09/04/2008Physician Payments
11/06/2013Physician Question about Clinical Trial Records
03/18/2003Physician Referrals
03/18/2003Physician referrals
04/02/2014Physician Referrals
05/30/2012Physician Requirement for HUD Use
05/30/2012Physician Requirement for HUD Use
06/13/2012Physician Withdrawal of Patient from Study
11/17/2015PI's/SubI's Entering Causality Data Directly into EDC
11/18/2015PI's/SubI's Entering Causality Data Directly into EDC
01/23/2007PI- Remote Sites
07/15/2014PI Access of EMRs to Assess AEs for Subjects Discontinued from IP; PI Seeking Contact Info from Friends/Family for Subjects Lost to Follow Up
12/03/2013PI Authorization and GCP Compliance
07/28/2014PI Conflict in Dual Role as Health Authority Employee
10/13/2011PI CV
09/23/2008PI Delegation of Duties
11/19/2014PI Duties
05/05/2015PI Eligibility
10/07/2011The PI Enter the "Date" For the Subject's Signature in ICF
01/18/2006Pilot Studies
04/14/2009Pilot Study
11/13/2015PI or SI Signature on Protocol
11/13/2015PI or SI Signature on Protocol
07/05/2015PI Oversight
12/20/2011PI Oversight Question
07/19/2012PI Oversight Responsibilities for Homecare Nurses Performing Clinical Trial Tasks
03/27/2013PI Qualifications
01/17/2007PI Question
12/15/2014PI Responsibilities
11/26/2008PI Responsibility
11/01/2013PI Retirement / Site Closure
05/31/2012PI Sabbatical Coverage
01/25/2007PI Signature on Adverse Event Reports
04/15/2011PI Signature on Lab Report
02/04/2010PI signature page in Investigator Brochure or Report of Prior Investigations
09/12/2007PI Sub-I
08/28/2012PI Subject Signoff at End of Study
04/30/2015PI Wants to Resign from a SMO because of Noncompliance
12/27/2012PI with Bachelor of Dental Surgery
05/07/2003Placebo-controlled trials
03/30/2011Placebo Controlled Studies
10/18/2006Placebo Controlled Trial
01/11/2010Placebo Run In and Deception
07/27/2012Placebo use in Clinical Research with Children
11/16/2010Place Security Finding
08/13/2014Planned Deviation
03/02/2011Please Assist with Question
08/04/2014Please Comment: CRA previously as Study Coordinator
05/15/2013Please Help!
11/23/2013Please Help Me with Possible Meaning of FDA "Approved" 'Controlled Clinical Trial'
07/23/2014Please Help Us Find the Best Path to FDA Approval of Our Anti-Cancer Agent
02/01/2006Please Provide Us with the Details
12/15/2013Please Respond - National History Day Interview (Topic: Clinical Research and the Study of Human Subjects)
07/23/2013Point-of-Care Device Interfacing in Clinical Trials
06/11/2012Point of Clarification: Regarding Reconsenting
01/23/2003Policy
10/22/2007Policy Clinical Labs
04/25/2006Policy on Charging Patients
03/30/2011Policy Question Social Media Use in Clinical Trial Patient Recruitment
08/03/2007Possible Conflict of Interest
08/31/2007Possible Double Payment of Expenses
11/02/2009Post-Dating a 1572
08/19/2008Post-Market Study - Consent IRB Requirements
08/21/2008Post-Market Study - Consent IRB Requirements-2
04/03/2008Post 2005 GCP E-mails
04/21/2015Post FDA Inspection of Clinical Site
05/09/2006Posting of Inclusion Exclusion Criteria
04/07/2015Post marketing Adverse Event Reporting
06/22/2012Post Marketing Adverse Events
05/31/2007Post Marketing Survey
02/09/2012Post Market Medical Device Regulations
06/13/2010Post Study AE, Unanticipated Problem Reporting
09/17/2010Potential Conflicts of Interest
06/20/2005Potential Investor
03/25/2009Potential Research Criteria
05/31/2011Potential Subjects Fasting Prior to Written Consent
09/17/2002Practical use of CCT guidance
11/23/2014Pre-Clinical and Clinical
06/06/2006Pre-Clinical Studies Using Human Tissues
07/24/2009Pre-consent
05/02/2012Pre-Screening and Protocol Design
09/23/2004Pre-Study / Initiation Visit Attendance Log
12/21/2011Preambles
04/24/2008Pregnancies of Female Partners of Male Subjects
04/10/2002pregnancy and human studies
02/08/2008Pregnancy as Adverse Event; AE before Randomization
06/09/2009Pregnancy During a Clinical Trial
04/10/2006Pregnancy Follow-Up
09/18/2007Pregnancy Test Before IC
04/19/2013Pregnant Partner Consent
03/04/2009Pregnant Partner of Subjects
03/14/2015Pre Initiation Visit
04/21/2011Pre Market Application
06/06/2002Preparation of IRB SOPs by the Institution
06/12/2013Preparatory to Research
01/14/2011Preparatory to Research - HIPAA
10/28/2013Prescribing IP
02/13/2009Preservation of Study Related E-mails
08/04/2008Pressure from IRB Chair
09/05/2006Previous FDA Inspection
02/17/2009Previous Medical History Records
11/04/2004PRIM&R Meeting Questions
03/10/2014Primary Care Physician - IRB Approval Required?
06/06/2013Primary Care Physician Notification
08/05/2004Primary responsibility for GCP training at a sponsor
02/24/2010Principal Investigator
02/17/2015Principal Investigator as the Chairman of IRB
05/03/2011Principal Investigator Question
12/05/2012Principal Investigator Supervision
05/29/2007Principal Investigator Unavailability
06/25/2007Principle Invesitgator- Can He be a Pharmacist
10/08/2012Principle Investigator CV
12/11/2013Printed Copies of EMR
02/01/2011Printed Medical Records as Source
08/24/2012Printing Emails
02/15/2007Printing of Clinical Trial E-Mail Correspondence
06/17/2009Print Material
10/03/2006Prisoners - FDA Regulated Study
04/08/2010Prisoners as Subjects in Research
11/21/2007Prisoners in Clinical Trials
10/09/2011Private Health Information Questions
06/10/2010Private Sectors
07/27/2009Probabilistic Sensitivity Analysis
02/10/2015Process for IRB Transitioning to Non-FDA IRB
08/28/2008Process for Notifying FDA
04/11/2008Processing IND Safety Reports
03/25/2002Products in the treatment of depression
10/22/2012Promotion and Charging for an Investigational Product
01/13/2004Proper Documentation for Changes to FDA Form 1572
05/17/2011Proper Process/Organization for IRB Consolidation
11/10/2005Proposed rule status
08/20/2012Prospective Approved Protocol Deviations
07/13/2011Prospective Protocol Waivers
11/29/2010Prospective Study with Survey
04/30/2007Protecting Human Subjects Film
02/02/2006Protecting Workers Who Participate in Research
03/23/2012Protection of Research Documentation
10/22/2012Protocol
09/24/2012Protocol Addendum Question
10/08/2003Protocol amendment
01/29/2015Protocol Amendment
11/20/2014Protocol Amendment Extending Duration of Multicenter Study - Questions about Sites Choosing Not To Continue Beyond Original Protocol Period
07/14/2011Protocol Amendment or Administrative Letter Follow-up
06/19/2007Protocol Amendment Question
09/28/2005Protocol Amendments
03/07/2006Protocol Amendments
07/01/2008Protocol Amendments vs. Correction or Administrative Change Letters
01/03/2011Protocol Changes
10/24/2008Protocol Deviation- Unanticipated Problem
10/24/2008Protocol Deviation- Unanticipated Problems
07/07/2006Protocol Deviation- Violation
10/06/2008Protocol Deviation-Violation
04/01/2003Protocol deviation/violation
07/05/2012Protocol Deviation Documentation
06/27/2008Protocol Deviation or Protocol Amendment as Alternative to Compassionate Use Exemption
04/04/2006Protocol Deviations
06/06/2008Protocol Deviations
04/17/2009Protocol Deviations
07/14/2009Protocol Deviations
03/02/2012Protocol Deviations
09/12/2014Protocol Deviations
04/24/2008Protocol Deviations and Clinical Study Reports
05/29/2008Protocol Deviations and Clinical Study Reports-2
06/13/2008Protocol Deviations and Clinical Study Reports-3
01/13/2009Protocol Deviations Discussion
11/01/2004Protocol deviations vs. protocol violations
08/29/2007Protocol Deviations vs. Violations
10/07/2009Protocol Deviation Versus GCP Violation
08/09/2005Protocol Disapproved
10/20/2009Protocol Eligibility Criteria
12/03/2009Protocol Exception Granted to [Redacted]
03/03/2003Protocol for clinical trial
05/28/2008Protocol Methodology
11/03/2015Protocol Non-Investigational Meds
04/05/2005Protocol procedure question
05/22/2002Protocol Question
06/10/2014Protocol required but also Standard of Care Procedures in the Consent
01/19/2007Protocols
02/08/2013Protocols
06/15/2007Protocol Signature Page
04/11/2013Protocol Signature Page
12/12/2006Protocol Signatures
01/13/2010Protocol Signatures GCP
12/21/2010Protocol Steering
10/27/2011Protocol Submission
05/07/2003Protocols versus Sponsor Protocols
04/15/2014Protocol Training Documentation
02/28/2013Protocol Training Requirements
08/02/2005Protocol Violation and Deviations Definitions
01/20/2010Protocol Violations
10/30/2003Protocol violations/deviations
10/26/2005Protocol violations versus deviations
10/06/2008Protocol Violation vs Deviation
01/08/2008Protocol Waiver Question
05/06/2003Protocol Waivers
10/26/2006Protocol Waivers
11/17/2008Protocol Waivers
06/18/2014Protocol Waivers
10/02/2009Protocol Waivers Inquiry
11/30/2006Protocol Waivers Study Criteria
05/12/2010Providing AE Info in Response to a Company Request
02/05/2014Psychiatry Trials - Source Documentation
09/05/2008Psychotropics for Children in Foster Care
12/18/2009Publication of Negative Results
01/15/2008Publication Policy
07/14/2006Publications
11/18/2011Publications after Termination of Research Study
03/23/2005Public Disclosure Timing/Language Questions
05/31/2012Public Feedback on RBM Guidance
09/15/2006Public Health Surveillance Research
01/09/2007Publicizing FDA Guidelines
10/23/2009Public Safety and Clinical Trials
04/04/2006Publishing Clinical Results
01/10/2008Publishing Results
12/08/2011Publishing Trial Results
05/06/2010Purging Documents
10/26/2006QA in Clinical Trials
03/20/2006QA Program
08/09/2012QA Review of Blinded Drug Paperwork
10/17/2002QA unit
05/20/2008QA Units
11/27/2002QISiteVisitProgram
07/15/2010Q on IRBs--Time Sensitive
11/29/2005Q on the 1572
02/04/2003Qs for Stan Woolen
08/22/2003Qt about study visits
04/24/2009Qt Interval Guidance
11/13/2007Qualification Requirements for QA Responsible Person
07/14/2006Qualifications
02/17/2011Qualifications Required to Monitor Clinical Trial Data
08/21/2012Qualification to Conduct GCP Training
07/30/2010Quality Assurance Training in Clinical Trials
09/15/2003Quality Management
03/09/2012Quality of Life Questionnaires and Pill Diaries
08/15/2007Quality of Sub-Investigators
10/30/2006Quality System Approach to GCP Audits
04/08/2010Quality Systems - FDA Staff Manual Guide
03/20/2009Quality Systems and GCP
08/01/2014Quantity of Reserve Sample Required
01/28/2003Queries
03/03/2011Queries about ECRF and Final Report
02/12/2008Queries GCP
06/16/2009Queries on Back Translation and Signatures on Lab Reports
06/10/2010Query
10/26/2010Query
10/26/2010Query
11/13/2010Query
11/22/2010Query
11/23/2010Query
01/13/2011Query
04/07/2011Query
07/29/2011Query
06/11/2012Query
08/26/2012Query
10/29/2012Query
02/23/2013Query
10/04/2010Query-Central Monitoring
10/25/2012Query-Outside US inspections
01/15/2008Query - Submission of Investigator Information to an IND
10/28/2010Query?
11/22/2010Query?
10/07/2013Query about Form FDA 1572
04/14/2009Query About Investigator's Brochure
12/20/2005Query about SAEs
02/12/2013Query concerning Guidance
10/08/2010Query FDA-1572
03/31/2009Query Foreign Clinical Data
03/07/2012Querying Clinical Data after Site Close Out and IRB Closure
10/07/2011Query Monitoring
11/29/2009Query of Documentation of IC in Acute Studies
07/21/2009Query on 21 CFR Part 56.106
02/10/2012Query on addition of Statement in ICF
05/22/2012Query on Consent
12/01/2010Query on Data Management Systems
11/03/2009Query on EC membership
04/06/2010Query on Legally Acceptable Representative and Impartial Witness
10/04/2011Query on Obtaining Informed Consent
02/19/2010Query on Photo-ID of Patient
01/30/2008A Query on Principal Investigator Qualifications
09/26/2008Query Re-Timing of IND Submission Acquiring an NCT Number-1
09/26/2008Query Re-Timing of IND Submission Acquiring an NCT Number 2
08/03/2011Query Re: Current Version of Debarment Guidance
01/03/2011Query Re: Sponsor Protocol Deviation
05/16/2005Query re Declaration of Helsinki
12/31/2007Query Re Financial Disclosure SPOOS Tracking
01/04/2008Query Re Financial Disclosure SPOOS Tracking
10/05/2015Query regarding 21 CFR 312.68 and 21 CFR 812.145
01/07/2011Query regarding 1572
08/04/2011Query Regarding 1572 Form
05/11/2004Query regarding Accountability of Study Medication
05/31/2010Query regarding Bioequivalence study in [Redacted]
04/20/2011Query regarding CVs and if they Expire
09/23/2010Query Regarding FDA 1572 Form
09/27/2011Query regarding FDA Form 1572
11/18/2002Query regarding FDA Inspection data
01/19/2012Query regarding Financial Disclosure
04/10/2008Query Regarding Form 3455 3454
06/02/2011Query Regarding GCP
10/15/2010Query Regarding ICF Process
10/29/2010Query Regarding ICF Process
12/24/2011Query Regarding IMP Accountability in Clinical Trials
04/13/2004Query regarding Informed Consent Form
07/23/2009Query Regarding IRB Registration
11/22/2012Query Regarding Key Opinion Leader
05/24/2010Query regarding LAR being considered as IW
10/07/2011Query regarding Local Lab
09/06/2014Query Regarding Obtaining Medical History for Clinical Trials
08/08/2014Query Regarding Patient Sample Collection
09/03/2013Query regarding Plasma Storage in Refrigerator
06/18/2009Query Regarding Providing Copy of ICF to Study Subjects.
06/16/2004Query Regarding Quality Control Documentation for Laboratories
09/17/2004Query regarding Translations
10/01/2009Query Regarding Version of Date of ICF
12/03/2009Query Re IBs in an IND-Exempt Study
03/27/2008Query Related to Case Report Form (CRF)
09/02/2015Query related to IRB's Approval
04/06/2006Query Re Monitor Observing Clinical Trial
01/27/2015Query re Principal Investigator on Clinical Trials
01/25/2008Query Resolution Source Documents and Copying
01/25/2008Query resolution source documents and copying
10/08/2004Query to CDER Drug Information
04/12/2002Query to FDA
04/27/2004Query to FDA
05/27/2004Query to FDA
04/05/2002Question
06/25/2002Question
08/02/2002Question
08/30/2002Question
01/23/2003Question
03/17/2003Question
07/31/2003Question
09/16/2003Question
10/24/2003A question
11/20/2003Question
05/30/2004Question
07/09/2004Question
07/25/2004Question
09/09/2004Question
09/10/2004Question
09/16/2004Question
09/17/2004Question
09/17/2004Question
09/20/2004Question
10/08/2004Question
10/18/2004Question
10/27/2004Question
11/16/2004Question
01/04/2005Question
02/02/2005Question
02/03/2005Question
03/10/2005Question
03/22/2005Question
04/16/2005Question
06/02/2005Question
10/06/2005Question
12/05/2005Question
05/24/2006Question
07/14/2006Question
08/04/2006Question
09/19/2006Question
10/05/2006Question
12/21/2006Question
01/25/2007Question
02/04/2008Question
02/15/2008Question
02/27/2008Question
03/27/2008Question
05/05/2008Question
10/10/2008Question
01/28/2009Question
06/24/2009Question
07/06/2009Question
09/23/2009Question
12/29/2009Question
01/14/2010Question
01/27/2010Question
02/18/2010Question
03/02/2010Question
04/28/2010Question
04/30/2010Question
06/28/2010Question
08/05/2010Question
08/25/2010Question
10/22/2010Question
11/12/2010Question
11/12/2010Question
11/24/2010Question
12/01/2010Question
12/10/2010Question
03/24/2011Question
06/15/2011Question
06/30/2011Question
07/06/2011Question
10/21/2011Question
12/02/2011Question
01/04/2012Question
01/17/2012Question
01/26/2012Question
03/29/2012Question
04/21/2012Question
04/25/2012Question
06/07/2012Question
06/21/2012Question
06/22/2012Question
06/25/2012Question
07/30/2012Question
08/26/2012Question
09/07/2012Question
10/02/2012Question
10/05/2012Question
10/16/2012Question
12/24/2012Question
03/18/2013Question
10/15/2013Question
03/20/2014Question
05/05/2014Question
06/02/2014Question
03/21/2015Question
10/23/2015Question
11/25/2015Question
10/16/2007Question - 1572 Box #3
08/06/2004Question - adverse events
05/03/2010Question - Box 11 of FDA Form 1572
12/13/2006Question- Clinical Protocol Content
07/03/2013Question - Communication with the Clinical Trial Patient
03/25/2008Question-Data Management
07/09/2014Question - Documentation of Protocol Specific Training
08/30/2011Question - FDA Form 1572 - Staff Residents on Rotations
04/07/2015Question -GCP
12/11/2010Question-GCP
01/06/2010Question - Initiation Visit Monitoring Report
08/19/2003Question- National bank of volunteers
04/09/2007Question - Pregnancy Follow-up
11/21/2011Question - Regulations and Investigator Initiated Research
03/16/2009Question- Repeat Consent Because Of Time Lag
08/23/2011Question - Specific Trial
06/11/2003Question - Study drugs
05/05/2014Question - Sub-I Support Of PI Responsibilities for a Limited Time
04/01/2009Question- Timing of IRB Review of Phase II Protocol
02/29/2012Question-two consent forms
10/13/2003Question - Unacceptable , Disqualified IRBs
08/20/2013Question - Vendor Oversight
09/20/2011Question/Clarification Regarding 1572 Signature
09/18/2012Question/Error about 21 CFR § 50.25(c)
08/05/2004Question/ Protocol Waivers
04/05/2002Question 3
12/18/2008Question 1572
08/13/2014Question: Can a Study Subject Act as an Impartial Witness?
10/29/2014Question: Clinical Trials Database
03/22/2011Question: FDA 1572 form from foreign Investigators
03/24/2011Question: FDA 1572 Form from Foreign Investigators
03/25/2014Question: FDA support of 2013 Declaration of Helsinki
05/11/2010Question: Form 1572
02/01/2010Question: Form FDA 1572
05/02/2011Question: Guidance for Sponsors, Clinical Investigators and IRBs - 1572
12/09/2010Question: Regarding change in trial site facility/reporting obligation
09/30/2014Question: Siblings in Study for Rare Disease in Pediatric Population
10/06/2005Question: Study drug may be mailed?
08/18/2005Question: Subpart D regulations/Pharmacists on IRBs
07/18/2012Question: Whether or Not a Sponsor Can Be In the Direct Contact with the Subject
11/02/2004Question?
11/01/2006Questionable Practices in Developing Countries
02/14/2007Question About 5-Day Reports for Emergency Use
09/09/2011Question about 21 CFR 50.25(C)
06/15/2011Question about 21 CFR Part 11 and IRBs
02/04/2003Question about 1572
12/24/2009Question About 1572
05/07/2013Question about 1572 and Clinical Research Center
10/25/2011Question about 1572 Document
09/10/2013Question about Abbreviations
02/16/2012Question about Academic Medical Center Labs
03/28/2012Question about Addendum to Statement of Investigator - Form FDA 1572
08/22/2008Question About Adding Sites to Box 4 of 1572
11/25/2008Question About ADE Collection in Medical Device Trial
03/24/2014Question about Adverse Event
03/25/2014Question about Adverse Event
05/19/2015Question about Adverse Event Reporting
04/13/2015Question about Adverse Events
09/02/2005Question about Ages of Research-Volunteers
01/29/2015Question about a Medical Food in Research Proposal
10/01/2009Question About Annual Re-Approval of Research Protocols
05/19/2004Question about a regulation in Clinical Trials
06/14/2004Question about a regulation in Clinical Trials
07/25/2012Question about Auditing a Study with Home Health Follow-Up
07/21/2015Question about Biomarker Testing
10/05/2007Question About Central Laboratories and Clinical Research
01/15/2015Question about Certified Copy of Original Information
01/26/2012Question about Changing Study Personnel
03/13/2012Question about Children Participating in Research
04/10/2008Question about CLIA
08/13/2015Question about Clinical Data
01/23/2012Question about Clinical Drug Trials
04/20/2015Question about Clinical Investigations
06/25/2010Question about clinical trials
07/19/2006Question About Clinical Trials and Approval
06/28/2012Question about Collection of Mortality Status after Withdrawal of Informed Consent
05/28/2009Question about Compassionate Use
05/13/2011Question about Completing FDF and FDA 1572 Forms
10/20/2010Question about Completion of FDA 1572
10/21/2010Question about Completion of FDA 1572
09/11/2007Question About Conscious Sedation
08/05/2011Question about continuing review - IRB - FDA Regulated Test Article- DRUG (UNCLASSIFIED)
09/18/2009Question about CRA
02/10/2011Question about CRF Collection Requirements
06/03/2009Question about CROs and Devices
10/29/2009Question About CSR
02/09/2015Question about De-Identification of Study Records
02/09/2015Question about De-Identification of Study Records
09/11/2006Question about Declaration of Helsinki
06/19/2012Question about Declaration of Helsinki
08/21/2013Question about definition of Certified Copies
02/27/2013Question about Definition of Pediatric Research
12/31/2014Question about Disclosing FDA-Funded Trial Results on ClinicalTrials.gov
08/30/2005A Question about Drug Trial in an International Setting
08/26/2011Question about Electronic Signatures vs Paper Docs
05/26/2009Question About Electronic Storage
08/10/2011Question about eligibility in a clinical trial based on age
01/11/2006Question About Exception to Informed Consent (Emergency Settings) Research (2)
12/30/2003Question about expedited amendments and continuing reviews
04/12/2012Question about Expedited Category #1(b)(i)
02/23/2012Question about FDA inspection
06/25/2012Question about FDF and Phase IV Studies
08/15/2013Question about Fecal Transplants
03/31/2011Question about Financial Disclosure
03/17/2010Question about Financial Disclosure by Clinical Investigators Guidance for Industry
01/21/2014Question about Financial Disclosure Form Investigators
01/09/2015Question about Financial Disclosure Form Investigators
09/27/2012Question about Financial Disclosure Update
01/19/2012Question about Form 1572
04/30/2013Question about Form 1572
06/14/2013Question about Form 1572
09/23/2015Question about Form 1572 for Other Countries
05/29/2013Question about Form 1572 Statement of Investigator
08/17/2010Question about From FDA 1572
09/03/2002Question about GCP
03/14/2003Question about GCP
02/19/2004Question about GCP Audits
03/22/2013Question about GCP for Data Collection and Device Used for Both Research and Non-Research Purposes.
05/26/2006Question About GCP Regulation
06/06/2005Question about GCP Training
09/09/2011Question about GCP Training
02/06/2006Question About Good Clinical Practice
06/16/2006A Question About ICF
06/19/2013A Question about ICF Process Statement on Source Document
05/07/2010Question about ICH E6
09/02/2013A Question about Impartial Witness
09/03/2013A Question about Impartial Witness
03/16/2006Question About Informed Consent
03/27/2006Question About Informed Consent
12/19/2013Question about Informed Consent
06/21/2006Question About Informed Consent Regulations for FDA Regulated Studies
02/27/2009Question About Inspections in India
11/16/2010Question about International Clinical Trials
05/20/2010Question about interpreting adherence to GCP (vs Federal Regulation)
02/26/2008Question About Investigator-Initiated Study
10/26/2004Question about Investigator Brochures Submitted for Clinical Research Studies
01/27/2012Question about IRB and Software Validation
07/25/2014Question about IRB Audits
12/11/2003Question about IRB membership
01/11/2010Question about IRB Reporting Requirements at 21 CFR 56.108(b)
08/06/2010Question about IRB Review
07/19/2013Question about ISO 14155_2011 (GCP for Medical Device Studies)
07/19/2010Question about Listing Manufacturers of [Redacted] on Form 1572
09/22/2010Question about Local Laboratory
04/25/2013Question about Mailing Re-consenting Process
06/18/2003Question about mandatory training
01/05/2015Question about Minimal Risk NSR Device Studies at Continuing Review
07/30/2015Question about Minors and Proof of Guardianship
02/27/2010Question about Name Change
06/18/2013Question about Need for Inter-Institutional Agreements when Study is not Federally Funded if FWA Box is Unchecked
04/10/2002Question about off-label use of medications and the informed consent document.
07/12/2013Question about Ownership of Closed Clinical Trial Records
05/06/2011Question About Past IND Trials Data
03/17/2011A Question about Pediatric Trial ICF
08/11/2010Question about Phase One Study
01/22/2015Question about Physician Investigator
11/11/2011Question about PI
04/25/2013Question about Possible Serious GCP Breaches Detected by Sponsor
02/05/2012Question about Pre Screening
12/14/2015Question about Protocol Deviation
08/10/2011Question about Radiology Facilities on the 1572
05/03/2010Question about Registering a Clinical Trial
02/19/2004Question about Regulations Pertaining to Retention of Clinical Trial Specimens
10/22/2003Question about reporting an adverse event
05/15/2012Question about Requirements for Curriculum Vitae
12/22/2008Question about Research
07/16/2010Question about Retention of Medical Records by Clinical Investigator
03/15/2006Question About Review Boards in General
01/25/2008Question About Risks in Post-Approval Studies
11/15/2011Question about Screening Tests
05/11/2011Question about Section #8 of Form FDA 1572
11/12/2008Question About Section 6 FDA Form
07/27/2015Question about Signatures on Source Documentation
06/21/2006Question About Site Name on Regulatory Documents
04/11/2013Question about Source Documentation
05/16/2013Question about Sponsor of an IND
03/01/2011Question about Storage
03/06/2012Question about Study Close Out and Pharmaceutical Drugs
11/06/2015Question about Study Site Equipment
07/23/2012Question about Subinvestigators
12/06/2013Question about Subject Compensation
07/30/2013Question about Submitting Form 3674
02/14/2006Question About Television Interview
08/25/2004Question about the 1998 Information Sheet update on guidance for IRBs and clinical investigators
07/29/2014Question about the Definition of CI vs. PI
12/06/2010Question about the Definition of Key Research Personnel in Clinical Trials
12/15/2011Question about the Form 1572
07/31/2003An question about the integrity of the trial conduction
04/02/2009Question About the Study Title in a Consent Form
07/12/2010A Question about the Updated ICF Process
07/12/2010A question about the updated ICF process
02/22/2005Question about the Use of SAS
04/30/2003Question about Timing of Study-related Procedures
08/02/2010Question about Tissue Study
10/27/2014Question about Transferring Subjects from One Site to another Site
08/25/2008Question about Unblinded Monitors
12/13/2013Question about whether a published clinical study must be posted on clinicaltrials.gov for use in a 510(k)
08/16/2010Question about Which Patient Group Needs to be used for SAFETY Reporting.
10/05/2009Question About Written Chemotherapy Orders
10/19/2009Question about [Redacted] Compassionate Use Case- IRBReview
08/26/2010Question Arising from Guidance on Electronic Medical Records
11/04/2002Question clarification
01/21/2014Question Clinical Meaningful Difference
08/10/2005Question Concerning 21CFR11
02/11/2010Question Concerning 1572
10/20/2004Question concerning 1572 Section 4 and 6
04/09/2012Question Concerning ACLS Certification for Investigator Sites for Clinical Trials
03/16/2005A Question Concerning a Radiologist and Form 1572
06/19/2013Question concerning Authorization to Release Medical Records
01/23/2009Question Concerning Clinical Trials
02/18/2015Question concerning Consent and Retention of Records
11/16/2011Question Concerning Consenting Blind Research Subjects
06/07/2006Question Concerning Essential Documents
12/30/2010Question Concerning FDA Accredited Companies in [Redacted]
12/16/2004Question Concerning Guidance for IRB and Clinical Investigators - 1998 update
12/16/2005Question concerning guidance for IRB and clinical investigators - 1998 update
12/16/2005Question Concerning Guidance for IRB and Clinical Investigators - 1998 update
09/08/2015Question concerning Inform Consent from Parents and Assent on Minors
09/17/2004Question concerning informed consent and translators Dear
09/02/2010Question concerning Informed Consents
12/29/2013Question concerning Language which should be used in FDA 1572
03/01/2011Question Concerning Length of Clinical Trials
11/04/2010Question concerning Patient Diaries and Forms
02/15/2012Question Concerning the Use of Patient Initials and Birth Date on a Case Report Form
08/30/2004Question Concerning the Validity of Approval Letters Received in Email Format
09/10/2004Question CRO accreditation
04/15/2014Question Definition of an Investigator in a Clinical Trial
09/23/2011Question Drug Accountability in a Clinical Project Database
05/27/2008Question Expanded Access
03/24/2011Question FDA 1572 Form from Foreign Investigators
06/12/2006Question FDA Regulation on Clinical Trials
03/25/2014Question FDA Support of 2013 Declaration of Helsinki
01/11/2010Question for 1572
05/26/2015Question Foreign Clinical Study and Form 1572
01/25/2010Question for FDA GCP/21 CFR part 11: requirement audit trail, solely electronic OR combination electronic/paper-based audit trail fulfills too?
04/29/2008Question Form 1572
05/09/2008Question for Transnational Clinical Research Subjects with Visits in Different Countries During the Study
07/21/2004Question For You
02/18/2013Question from a CRO about Communication Documentation- Email contains a url listed on [Redacted]
02/05/2013Question from a CRO about Communication Documentation - [Redacted]
03/01/2006Question from a Sponsor
06/29/2006Question from a Sponsor-Investigator
12/11/2006Question from CDER
12/15/2006Question from Harvard Student
02/03/2009Question from Industry
11/08/2013A Question from the SOCRA Conference in Atlanta this Week
05/07/2010Question from [Redacted] IRB
05/04/2011Question from [Redacted] IRB regarding Data Collection after Study Closure
12/20/2010Question I can't find the answer to
01/20/2006Question IC Related to Research or Treatment
08/31/2011A Question I Hope You Can Help in the Right Direction
09/24/2004Questioning Regarding Results Handling
07/06/2010Question Investigator Financial Disclosure
11/21/2007Questionnaire Trial A
04/11/2014Question Need to Re-consent Subjects Participating in an Investigational Study
01/13/2011Question New Required Element for Informed Consent
05/28/2002a question of AE definition
09/08/2009Question of Documenting Eligibility
05/23/2012Question of FDA regulation
11/23/2010Question of GCP and Research on Food
02/04/2011Question of Guidance Information Sheet Guidance for IRB PI and Sponsors Clinical Investigator Administrative Actions Disqualification
08/09/2013Question of Needed Cautionary Statement on Clinical Supplies
04/20/2004Question on 21CFR11
05/01/2012Question on 1571 and Cross-Filing IND Safety Reports
05/04/2011Question on 1572 and Medical Imaging
08/07/2008Question on 1572 Block 1 and 3
05/24/2011Question on 1988 Guideline for Monitoring
12/08/2008Question on an Unanticipated Problem
05/27/2015Question on BA/BE Studies Exempt from IND Safety Reporting to the IRB
08/20/2009Question on Blood Storage in Sub-Studies
07/16/2012Question on CFR 45 § 46.115
09/24/2009Question on CI Discontinuation
04/01/2015A Question on Clinical Trial
04/03/2003Question on Clinical trial forms required by the FDA
08/28/2015Question on Clinical Trials
07/06/2010Question on Clinical Trials in Puerto Rico
12/09/2009Question on Completing 1572
05/19/2004Question on completion of laboratory section of Form FDA 1572
12/15/2015Question on Complying to 21CFR 56.107 (e) Conflict of Interest
09/29/2008Question on Conducting Trials at Foreign Clinical Sites
05/23/2008Question on Confidentiality in Clinical Trials
03/18/2010Question on Confidentiality of Clinical Trials
12/21/2012Question on consistency between FDA 1572 form and site delegation log
03/31/2009Question on Continuing Review Dates
04/18/2005Question on CSUCT Reference
04/12/2010Question on Decoding Treatment for Blinded Trials Post Study Completion
05/27/2004QUESTION ON DEVICE GCP INSPECTIONS
06/09/2010Question on Disclosable Financial Agreements
09/08/2009Question on Documenting Eligibility
07/13/2011Question on Draft guidance on Financial Disclosure by Clinical Investigators
09/25/2013Question on e-signature implementation
07/03/2002Question on Eligibility Waivers
01/23/2014Question on EMR access
10/09/2008Question on FAQ Guidance
04/20/2010Question on FDA 1572 Form - Temporary Replacement of PI
07/08/2014Question on FDA Form 3674
03/13/2012Question on FDA Guidance for Continuing Review Intervals
06/03/2011Question on FDA Response to an Investigator's Response to a FDA Form 483
06/03/2011Question on FDA Response to an Investigator's Response to an FDA Form 483
04/01/2005Question on Financial Disclosure
02/24/2011Question on Financial Disclosure
05/03/2004Question On Follow-Up
07/22/2009Question on Form 1572 Block 4 Clinical Labs
05/30/2013Question on FWAs
11/02/2009Question on GCP
06/05/2014Question on GCP 4.8.10, 21 CFR 50.25 and FDA Access to Medical Records for Inspection/Monitoring (UNCLASSIFIED)
11/03/2010Question on GCP and Foreign Clinical Trials
10/29/2013Question on GCP Data Integrity
06/27/2005Question on GCP policy
03/27/2014Question on GCP Training for a Site
11/08/2013Question on Good Clinical Practice regarding Record Retention for DMF
03/12/2014Question on Good Clinical Practice regarding Record retention for DMF
10/16/2008Question on Guidance Document-Acceptance of Foreign Clinical Studies
11/04/2011Question on Guidance for Oversight of Fully Outsourced Clinical Trials
11/25/2014Question on How to Complete Gender in CRF
04/16/2010Question on Human Research Study Guidance
07/06/2009Question on ICF Practice at Clinical Sites
04/05/2012Question on ICF signature
07/26/2008Question on incentives
07/26/2008Question on Incentives
11/10/2009Question on Informed Consent and Protocol Amendments to IND
03/30/2011Question on Informed Consent Document - Signatures and Dates
02/16/2012Question on Informed Consent Elements, 21 CFR § 50.25(c)
11/28/2014Question on Insurance for Sponsors
02/19/2015Question on Interpretation of GCP
01/20/2004Question on Investigational Plans/IRBs
01/21/2004Question on Investigational Plans/IRBs
02/25/2009Question on Investigator's GCP Qualification
05/24/2004Question on Investigator/Subject Ratios
12/30/2012Question on Investigator Payment Incentives
05/12/2005Question on Investigator Regulatory Binder
05/10/2011Question on Investigator Statement of Agreement for Devices
04/18/2002Question on labeling process of clinical products
04/08/2009Question on LAR Impartial Witness
06/24/2013Question on New (Feb 2013) FDA Guidance on Financial Disclosure for Clinical Studies
04/07/2006Question on Non-English Speaking Subjects
03/13/2012Question on Observational/Non-Interventional Studies
09/02/2003Question on Old Regulations
08/08/2013Question on Original vs Copies of Regulatory Documents
04/19/2011Question on Patient-Reported Outcomes (PRO)
04/28/2010Question on Patient Eligibility to Enter a Clinical Trial
12/05/2005Question on Phase I Drug Trials
11/10/2010Question on PHI in Research Subject Files
09/10/2014Question on Pre-Existing Condition Diagnosed during AE Reporting Period
01/20/2010Question on Presence during Pt Visit
02/21/2012Question on Proposed Rule - Docket No. FDA-2008-N-0115, Published in FR Volume 75, No. 33, 2/19/2010
12/10/2010Question on Protocol Waivers
08/11/2010Question on Record Retention
10/07/2013Question on Reporting for Device Trials
10/02/2012Question on Reporting of Unanticipated Problems Involving Risks to Subjects or Others
01/27/2010Question on Requirements for Subject Lost to Follow Up
08/25/2014Question on Retention Time Period for Plasma Samples
12/01/2008Question on Safety Reports Submission
06/03/2014Question on Screening
09/02/2009Question on Source Documentation of Causality for AEs and Abnormal Lab Values
06/11/2008Question on Source Documents
04/21/2011Question on Sponsorship Responsibilities
04/25/2011Question on Sponsorship Responsibilities
02/27/2008Question on Status of Draft Guidance
10/01/2013Question on Study Staff Not in the Direct Employ of the Investigator
06/29/2011Question on Study Subject Material -Informational Wallet Cards
03/08/2013Question on Subject Lost to Follow-Up
07/03/2004A Question on Subjects at Foreign Sites
02/01/2013Question on Subject Screening Log Purpose
04/30/2015Question on Subjects Deceased prior to End of Study
09/24/2014Question On Submission of Investigator Information to FDA for IND Protocol Investigators, Domestic and Foreign
04/14/2014Question on Text in ICF Disclosing Treatment or Dose after Trial is Over
05/20/2010Question on the Rules of Inclusion/Exclusion Criteria
07/23/2014Question on the Use of the Short Form Informed Consent CFR 50.27(b)(2)
04/01/2015Question on Transfer of Study Records
05/17/2006Question on Unanticipated Use of Blood Sample Aliquots After Study Completion
10/25/2013Question on Withdrawal of Consent vs. Withdrawal of Trial
06/18/2012Question Patient Referral Payments
09/21/2015Question Pertaining to Enrolling a Subject into a Clinical Trial
10/25/2012Question pertaining to Forms FDA 1572
08/13/2015Question Pertaining to Re-Consenting and Notifications
10/14/2005Question Please
08/26/2011Question Please
04/24/2014Question Re. Warning Letters
12/29/2009Question Re 21CFR56.108(b)- Reporting Requirements
11/14/2005Question re 1572
04/12/2013Question Re 1572 Completion - Labs
04/12/2013Question re 1572 Completion - Labs
07/24/2008Question Re 1572- Blocks #1 & 3
06/03/2002Question re: categorization/classification
08/17/2012Question re: Change of Principal Investigator at a Clinical Site
12/01/2014Question Re: Consent Form
06/04/2015Question re: Devices
05/09/2011Question re: Electronic Medical Records and Certified Copies
12/23/2014Question re: GCP
05/08/2013Question re: IATA Certification
01/30/2003Question re: NIH
03/19/2015Question re: Original (Wet Ink) ICFs
06/14/2002Question re: PI Status
03/06/2003Question Re: release of personal patient info to ECOG
07/01/2013Question re: Sponsor Directive to Enter Dates in EDC for Visits which did not occur
11/28/2012Question re: Survey Methods and Protocol Compliance
06/26/2009Question Re AE Reporting and Cont. Review
06/17/2009Question Re Availability of Revised Form FDA 1572
12/29/2009A Question Re Block #1 of FDA 1572
09/15/2009A Question Re Block #6 of FDA 1572
02/04/2008Question Re Clinical Trials
09/30/2012Question Re Discharge Summary as a Source Document
03/26/2008Question RE FDA Access to Investigator Financial Records
02/12/2003Question re FDA Form 1572
12/30/2003Question Regarding "Guideline for Good Clinical Practice"
01/24/2014Question Regarding "Over Enrollment" in a Clinical Trial
10/03/2012Question regarding 21 CFR 50.25(c) Requirement
10/15/2012Question regarding 21 CFR 50.25(c) Requirement
08/27/2009Question Regarding 21 CFR 56.106 IRB Registration
02/13/2013Question regarding 21 CFR 312.57(c)
11/20/2014Question regarding 21 CFR Part 11
10/15/2009Question Regarding 21CFR 312.10 Waivers
12/17/2004Question regarding 21CFR Part 50.25(a)(5)
12/04/2009Question Regarding 50.25 (a)(4)
02/25/2008Question Regarding 483s
03/03/2008Question Regarding 1572
12/02/2011Question regarding 1572 Box # 3
01/31/2013Question regarding 1572 Form
10/18/2006Question Regarding 1572 Laboratory Entries
06/10/2015A Question regarding 1572 Laboratory Section
09/15/2014Question regarding a 1572
07/13/2004Question Regarding Acceptable Limits of Quality
01/25/2013Question regarding a CIIL VAI Deficiency Code
01/31/2013Question regarding a CIIL VAI Deficiency Code
07/22/2008Question Regarding Additional Safety Measures
08/17/2004Question Regarding Advertisement
06/01/2011Question Regarding Advertisements Submission to IRBs
03/18/2010Question Regarding AE on Source Documents
10/29/2009Question Regarding AE Reporting of Clinical Trial
02/23/2006Question Regarding a Subject Re-Entering Study
03/23/2010Question Regarding Box 4 of the FDA Form 1572
05/18/2010Question Regarding Box Number 7
09/02/2011Question regarding Canadian Review of Research
11/28/2006Question Regarding Case Report Forms
04/16/2009Question Regarding Central Lab
11/06/2012Question regarding Change in PI after Site Closure
07/29/2009Question Regarding Clinical Site Suspensions
08/06/2012Question Regarding Clinical Study Reports (CSR)
01/22/2015Question regarding Clinical Trial
09/07/2011Question Regarding Clinical Trial Information ConductediIn China
09/17/2004Question regarding Clinical Trials
10/12/2004Question regarding Clinical Trials
11/23/2014Question Regarding Clinical Trials
04/26/2013Question regarding Clinical Trial Start and GDP
11/23/2010Question regarding completion of Form FDA 1572
02/04/2010Question Regarding Completion of Form FDA 1572 - Not found In FAQs of the Guidance Document
02/05/2015Question regarding Compliance and Enforcement of NIH Clinicaltrials.Gov Databank Requirements
04/20/2012Question Regarding Conduct of Clinical Trial
10/05/2006Question Regarding Consent Form
04/30/2002question regarding consent of illiterate volunteers
04/04/2011Question Regarding Consent to Deaf Patients
08/09/2012Question regarding Contraceptives
06/22/2011Question regarding Corrections to the Form FDA 1572
08/25/2010Question Regarding CRF Completion
08/02/2013Question regarding CT Participants
08/19/2003Question regarding CVs
10/16/2013Question regarding Data Systems in Research
10/27/2009Question Regarding Delegation of Authority
01/19/2011Question Regarding Delegation of Authority Log
05/12/2011Question regarding Device Trial
04/20/2012Question regarding Disqualification of Clinical Investigator New Rule
07/22/2009A Question Regarding Dropout
08/20/2004Question Regarding DSI Acknowledgement Of Investigator Response To 483
03/11/2008Question Regarding Education Provided by FDA
08/26/2010Question Regarding Electronic IRB Records
07/14/2010Question Regarding Electronic Signatures
03/25/2009Question Regarding Electronic Source Documents
07/08/2015Question regarding End of Trial
04/21/2003Question Regarding Enforcement
08/14/2009Question Regarding Excluding Females of Child-Bearing Potential
05/15/2015Question regarding Exculpatory Language in Draft Guidance on Exculpatory Language in Informed Consent August 19, 2011 vs FDA Frequently Asked Questions IRB
08/01/2006Question Regarding Fasting for Prep Prior to Consent
10/02/2009Question Regarding FDA-Regulated Studies
11/16/2005Question regarding FDA 1572
06/17/2013Question regarding FDA 1572
11/20/2013Question regarding FDA 1572
03/09/2012Question regarding FDA 1572 & FDF
03/25/2008Question Regarding FDA Form 1572
04/04/2012Question regarding FDA Guidance
04/07/2006Question Regarding FDA Inspection of Records Identifying Subjects
12/13/2012Question regarding Filing with the FDA
06/24/2009Question Regarding Financial Disclosure
04/09/2009Question Regarding Fluidic Biospecimens
03/15/2006A Question Regarding Follow-up Period on a Newborn
03/23/2011Question regarding Form 1572
09/01/2015Question regarding Form 1572
03/26/2010Question Regarding Form FDA 1572
07/01/2010Question regarding Form FDA 1572
11/05/2009Question Regarding Form FDA 1572- Draft Guidance July 2008
06/21/2010Question Regarding Form FDA 3455
06/16/2010Question Regarding GCP
07/31/2002question regarding GCP/Federal Regulations
07/31/2002question regarding GCP/Federal Regulations
07/31/2002Question regarding GCP/Federal Regulations
01/04/2005Question regarding GCP studies and waivers
09/06/2013Question regarding GCP Training
01/09/2014Question regarding GCP Training for Investigators
07/07/2010Question Regarding Guidance Document
08/17/2012Question regarding Guidance on Form FDA 1572
04/13/2011Question regarding HIV Testing
08/04/2010Question Regarding How to Handle Potential Patient Contact with Sponsor
08/20/2008Question Regarding ICF Signing Data
04/23/2014Question regarding ICH E11 2.6.1 Pediatric Experts
04/18/2006Question Regarding IDE
08/31/2011Question Regarding IND Exempt Clinical Trials
03/27/2008Question Regarding IND Safety Reports
01/06/2004Question regarding informed consent
03/31/2004Question Regarding Informed Consent
10/10/2008A Question Regarding Informed Consent
03/17/2010Question regarding Informed Consent
07/15/2015Question regarding Informed Consent
06/14/2012Question regarding Informed Consent and Major Protocol Deviations
09/16/2002Question regarding informed consent documents on medical records
01/19/2011Question regarding Informed Consent Process
04/22/2015Question regarding Informed Consent Process
09/14/2006Question Regarding Informed Consent Signatures
10/20/2011Question regarding Informed Consent Verification
12/23/2011Question Regarding Initiation of Study Recruitment
01/17/2013Question Regarding Institutional Review Boards
01/17/2013Question Regarding Institutional Review Boards
05/13/2008Question Regarding Insurance Indemnity Specifications and Declaration of Hospitality Costs
10/28/2010Question Regarding International use of FDA
10/28/2010Question Regarding International use of FDA
10/23/2013Question regarding Investigator's CV
07/13/2009Question Regarding Investigator-Initiated Research Study of Spinal Fusion Prototype
02/20/2015Question regarding Investigator 1572 Requirements
03/30/2010Question Regarding IoRs
02/27/2012Question Regarding IRB Approval of Participant Letter for Closed Research Site
07/21/2013Question Regarding IRB Consent Translation SOP
06/24/2010Question Regarding IRB Expedited Approval
10/24/2011Question regarding IRB oversight
09/22/2009Question Regarding IRB Registration
09/21/2012Question Regarding IRB Review of Generic Materials
07/25/2013Question regarding Labeling of Investigational Drug Product
07/29/2013Question regarding Labeling of Investigational Product
08/04/2008Question Regarding Laboratory Normal Ranges
10/13/2009Question Regarding Latest Guidance on Form FDA 1572
12/14/2005Question Regarding Legality of Sending Clinical Trial Supplies Directly to Patients
01/24/2014Question Regarding Listing of Study Sites on clinicaltrials.gov
03/08/2013Question regarding listing research coordinators as sub-investigators for studies involving investigational devices
08/31/2012Question regarding Local Modifications to a Multicenter Protocol
11/01/2012Question regarding Lost Documentation
08/11/2014Question Regarding Mandated OTC Supportive Medication in Trials
06/24/2011Question Regarding MD or DO per Study or per Site
04/10/2008Question Regarding Measuring Troponins in a Clinical Trial
08/19/2014Question regarding Modification of 1572 Layout
04/07/2011Question Regarding New Informed Consent Element Regulations - New Rule Effective March 7, 2011
05/06/2015Question Regarding Non-FDA IRB
01/08/2014Question regarding Non Interventional Studies and Investigator (PI) Financial Disclosures
10/27/2008Question Regarding Number of FDA Approved Sites
08/09/2006Question Regarding Off-Label Use NSR Device-2
06/30/2003A question regarding OHRP update
03/24/2015Question regarding Original Signed Consent Forms
01/23/2004Question regarding Part 50 Dear Ms.
02/16/2012Question Regarding Patient Relocation
02/23/2006Question Regarding Patient Stipends
04/08/2009Question Regarding Payment for Clinical Trial Subjects
04/08/2009Question Regarding Payment for Clinical Trial Subjects
11/13/2015Question Regarding Payment for Services
06/20/2013Question regarding Payments to Research Subjects
04/04/2011Question regarding PDFs
08/10/2012Question regarding permission from observational registry study participants for additional data collection
12/12/2006Question regarding Phase I trials
04/07/2011A Question Regarding PI's Responsibility on Expedited Safety Reports
08/04/2014Question Regarding PI Involvement in a Study
01/24/2013Question regarding Promotion of a Trial
06/12/2012Question regarding Proper Protocol
11/21/2013Question regarding Protocol Deviation
01/29/2013Question regarding Protocol Requirements
01/09/2013Question regarding Protocols and Protocol Amendments
01/30/2015Question regarding Protocol Waivers
05/07/2013Question Regarding Qualifications of a CRC
03/02/2005Question regarding quorum
08/10/2006Question Regarding Recording Certain Data on CRFs
09/07/2010Question Regarding Record Retention
05/09/2011Question regarding record retention
08/01/2006Question Regarding Recruitment Material
05/13/2009Question Regarding Recruitment of Subjects Prior to Notice of Approved IND
05/26/2012Question regarding Regulatory Documents Site Binders
05/14/2010Question Regarding Reporting Adverse Events
11/03/2009Question Regarding Requirements to Provide Structured Listings of all Investigator Comments in eCRF
08/28/2008Question Regarding Research Pharmacist and COI as IRB Member
05/30/2014Question Regarding Research Trials
02/12/2011Question Regarding Retention of Correspondence
04/23/2004Question Regarding Review of IND Protocols
05/11/2005Question Regarding Revised Informed Consents
08/27/2008Question Regarding SAE Definition of Relatedness and IRB Authority of SAE Review
10/30/2014Question regarding SAE Reporting
08/09/2010Question Regarding SAE Reporting in US Clinical Trials
11/13/2009Question Regarding Safety Report Submissions
01/15/2010Question Regarding Safety Report Submissions
10/29/2014Question regarding Section 4 of Form FDA 1572
08/15/2012Question regarding Signature and Date of the Consent Form
08/09/2011Question regarding Site Signature Sheet-Authority Delegation Log
02/07/2005Question regarding SPA
01/04/2011Question regarding Sponsor Monitoring Editing Notes (MENs)
11/23/2010Question regarding Sponsor worksheets to Site
12/16/2009Question Regarding Start of Study
12/03/2009Question Regarding Statistical Review of Clinical Trials
10/07/2004Question Regarding Status of FDA Guidance Document: Record Keeping of Clinical Investigators
10/08/2004Question Regarding Status of FDA Guidance Document: Record Keeping Of Clinical Investigators
05/25/2011Question Regarding Storage of Clinical Research Documents
09/24/2009Question Regarding Sub-Investigator and Investigator Training
10/30/2002Question Regarding Sub-Investigator on 1572
02/17/2009Question Regarding Subject Anonymity - Device Clinical Trials
01/26/2009Question Regarding Subject Compensation
08/17/2010Question regarding Subject Participation in Non-Drug Trial
08/30/2005Question regarding submission of 1572
03/08/2010Question Regarding the 1571 and Foreign Investigators
10/23/2012Question regarding the 1572
08/22/2013Question regarding the FDA 1572
06/04/2012Question regarding the FDA 1572 Form
08/04/2013Question regarding the FORM FDA 1572 (2/13)
05/24/2006Question Regarding the Illiterate Subject Inform Consent
08/24/2010Question Regarding the May 2010 FDA Informational Sheet Guidance for the Statement of Investigator (Form FDA 1572)
08/21/2011Question Regarding the Monitoring Guideline
11/13/2003Question regarding the need for IRB approval of a particular marketing study
11/16/2015Question Regarding the Prompt Reporting of Serious Adverse Events
04/13/2012Question Regarding the Subject Legal Representative/Witness Sign Off
01/02/2008Question Regarding the Use of a Short Form Consent
01/12/2010Question Regarding the Use of Short Form Consent
02/21/2008Question Regarding Timing IRB Review with an IND
02/10/2003Question regarding to compensation for injury
02/25/2003Question regarding to compensation for injury
12/07/2005Question regarding to Investigator Brochure
09/30/2005Question regarding to the patient "withdrew consent"
05/09/2008Question Regarding Tumor Sample Donation
12/01/2008Question Regarding UAP Reporting in a Clinical Trial
01/05/2011Question regarding Update of 1572
07/29/2010Question Regarding Validation of Training Learning Management Systems
05/15/2013Question Regarding Waiver of Informed Consent for Screening Purposes
10/30/2008Question Regarding Websites
04/20/2011Question Regarding Withdrawal of Consent
10/17/2014Question regarding Witness in the ICF Process
02/01/2012Question regards to Pre-screening / 1572 / Electronic Records 21CFR11
01/11/2012Question re GCP
01/11/2012Question re GCP
03/03/2006Question Re Gender ID
08/06/2013Question re Good Clinical Practice (GCP) Training at Clinical Research Sites
10/30/2015Question re Labs involved in Clinical trials
08/11/2010Question Related to Certified Copies According to CFR 21 part 11
11/16/2015Question Related to Clinical Trial
04/17/2006Question Related to Electronic Research Data Collection
07/02/2004Question Related To FDA Expectations For Sponsor Action On Warning Letters/Nidpoe Letters
09/08/2004QUESTION RELATED TO FDA REGULATIONS ON PATIENT WAIVERS
03/06/2012Question related to Financial Disclosure
03/05/2014Question Related to Finder's Fees
09/29/2008Question Related to Involvement of Principal Investigator
05/27/2014Question Related to Monitoring
02/25/2011Question related to Patient Records
04/07/2006Question Related to Pending SAE
06/26/2015Question Related to Role of Non-Physician Practitioners in Clinical Trials for Sites in US
11/10/2003Question related to source documentation
05/12/2005Question relating to Continuing Review
09/27/2006Question Re Marketed Drug and 21 CFR 5024
11/30/2006Question Re Multiply Trial Participation
09/14/2006Question Re Numbers of Studies at a Site
01/02/2008Question Re Participation in a Second Study
02/23/2006Question Re Protocol Deviations
07/15/2011Question Re SAE Reporting in a Non-IND Clinical Trial
08/21/2006Question Re Signatures on Approval Letters from IRBs
05/19/2008Question Re Sponsor Rep at Study Visit
09/03/2010Question re Subject Contacting the Sponsor Directly
09/06/2006Question Re Subject with SAE
08/15/2014Question Retention Samples for Reference Listed Drug (RLD)
07/19/2012Question re Virtual Companies
12/16/2014Question re_ IRB oversight
07/26/2002Questions
08/28/2003Questions
06/27/2005Questions
07/01/2005Questions
04/28/2006Questions
04/14/2008Questions
12/18/2008Questions
02/12/2009Questions
09/19/2010Questions
11/17/2010Questions
07/16/2008Questions, referred from DSI
04/01/2009Questions- Banned Devices
01/07/2012Questions about 1572
06/13/2014Questions about Collection of Data from Pregnant Subjects and Pregnant Partners
02/27/2008Questions about Cosmetic Testing
02/27/2012Questions about Emergency Use of an Investigational Agent
10/14/2005Questions About Gifts to Sites
06/24/2008Questions about Good Clinical Practice
03/22/2010Questions about Good Clinical Practice
02/24/2011Questions about ICF Signatures
10/30/2007Questions About IRB Memberships Composition
04/02/2003Questions about IRBs
12/22/2009Questions About Laws Broken
08/02/2010Questions about NSR determination of medical device by IRB
03/09/2012Questions about Promoting Clinical Trials On Behalf of a Pharmaceutical Client
06/25/2003A questions about report in trial master file
04/22/2013Questions about Research on DMAA
05/27/2006Questions About Single Patient IND Emergency
06/12/2006questions about single pt IND/emergency use
03/24/2015Questions about SUSAR
01/30/2003Questions about use of collected samples
09/06/2005Questions Arising from an Audit
10/26/2015Questions concerning FDA Form 3674
04/11/2012Questions concerning ICH-GCP and IND
04/11/2012Questions concerning ICH-GCP and IND
11/13/2013Questions concerning IND Protocol Amendments
01/13/2003Questions concerning Serious adverse events
03/29/2002Questions for Master's paper r/t informed consent & GCP education
12/10/2009Questions of GCP
02/03/2010Questions on Electronic Source Documents
12/29/2004Questions on Group C Cancer Studies?
08/20/2014Questions on Potential Conflict of Interest Related to Investigators of Clinical Trials
10/22/2010