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Israel – Guidelines for Clinical Trials

Ministry of Health

Pharmaceutical Administration

Jerusalem

Guidelines for Clinical Trials in Human Subjects

In accordance with the Public Health Regulations (Clinical Trials in Human Subjects) 1980

2006

Table of contents

General
Definitions
Contents of the guidelines
1.  Conditions for the conduct of a clinical trial in human subjects
2.  Contents of the application for a clinical trial
    2.1  Application form.
    2.2  Detailed plan for the clinical trial (trial protocol)
    2.3  Investigator’s Brochure (IB)
    2.4  Certificate of analysis from a recognized laboratory
    2.5  Informed consent form.
    2.6  Sponsor’s statement of commitment
    2.7  Declaration of Sponsor or Sponsor's representative in Israel 
         (Form 5)
    2.8  Document checklist.
    2.9  Notice for enrollment of participants.
    2.10 Letter to the attending HMO physician.
3.  Informed consent procedure
4.  Rules for the approval of clinical trial applications
5.  Authorities of the Director of a medical institution
6.  Special clinical trials and special amendments which the Director 
    of the medical institution is authorized to approve without 
    additional approval by the Ministry of Health
    6.1  Medicinal products (including biological products)
    6.2  Medical devices and instruments/medical equipment
    6.3  Miscellaneous: trials not involving medicinal products or 
         medical devices/medical equipment
    6.4  Amendments which the Director of the medical institution (or 
         designee) is authorized to approve without additional approval 
         by the Ministry of Health:
7.  Process of handling clinical trial applications or requests for 
    amendments therein
    7.1  Handling new applications for special clinical trials by the 
         medical institution
    7.2  Handling applications for special amendments in clinical 
         trials by the medical institution
    7.3  Handling new applications for non-special clinical trials and 
         non-special amendments by the medical institution:
    7.4  Handling new applications for non-special clinical trials by 
         the Ministry of Health
    7.5  Handling applications for non-special amendments by the 
         Ministry of Health
    7.6  Multicenter trials in Israel
8.  Single-patient access to investigational treatment
9.  Clinical trial agreement
10. Advertisement publications
11. Labeling of investigational products for clinical trials
12. Import of an investigational product for a clinical trial
13. Supply of an investigational product for a clinical trial
14. Amendments to application documents
15. Reports
    15.1 Safety reports on serious adverse events (SAEs) occurring 
         during a clinical trial
    15.2 Interim report / extension of trial validity
    15.3 Report on the completion of a clinical trial
    15.4 Annual report
16. Completion or discontinuation of a clinical trial
17. Continued provision of investigational product after completion of 
    the clinical trial
18. Supervision of clinical trials
    18.1 Supervision by the Ethics Committee
    18.2 Supervision by the medical institution
    18.3 Supervision by the Ministry of Health
19. Document retention
    19.1 Institutional Ethics Committee/Director of the medical institution
    19.2 Sponsor/Principal Investigator
    19.3 Pharmacy
20. Service fees
21. Required submission package for clinical trial applications
22. Additional forms for use after approval of the trial
23. Applicability
24. Update
25. Applicable documents
26. Circulation
Appendix 1: Waiver of requirement for informed consent for a clinical 
    trial in a medical emergency
Appendix 2: Insurance clause in contracts with commercial organizations 
    for conducting clinical trials in government hospitals

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