Archiving Records
(09/22/2008)

Question 1:

I have few questions pertaining to FDA understanding & regulations on following issues:

1. Source Document:

Can CRF act as source documents? Is this in line with ICH GCP & FDA requirements?

2. Monitoring:

Can site monitor perform the SDV while patient is @ site or hospitalized? Can CRA review & perform the SDV on the spot at site without violating any confidentiality norms? Can monitor see the patient & asked him whether he is been made aware of trial procedure appropriately & adequately?

3. Archiving

Can study documents archived @ CRO or Sponsor end incase institute or private clinic does not have adequate space, procedure to retain the documents as per regulatory requirements?

Answer 1:

1. Source Document:

Can CRF act as source documents? Is this in line with ICH GCP & FDA requirements?

Answer: If data are entered directly onto a CRF, then the original CRF becomes a source document. FDA's official guidance, the ICH E6 "Good Clinical Practice: Consolidated Guidance," section 8.3.13, states that source documents "...include original documents related to the trial, to medical treatment, and history of subject" and that they should be maintained by the investigator/institution. Although the next section in ICH (8.3.14) says that a copy of the CRF should be maintained in the investigator's files, with the original being sent to the sponsor, if the original CRF has become a source document (by virtue of being the first place in which study-related information has been captured onto a durable medium) then this suggests that the original CRF should be maintained at the investigator's site (in keeping with 8.3.13), and a copy sent to the sponsor. Having said that, as I said earlier, there is nothing in the regulations that would prohibit the practice of copying a CRF page, certifying it to be a true, accurate, and genuine copy, and using it as a source document. You may also find the advice in section 6.4.9 helpful; that section states that the study protocol should include "identification of any data to be recorded directly on the CRFs (i.e., no prior written or electronic record of data), and to be considered to be source data."

There are pros and cons related to the use of CRF pages to capture data. In general, best record keeping practices make maximum use of indigenous site records and minimize the need for transcription. So, if the CRF page is to be used to collect the data, it would be preferable to use the original rather than making a copy and having to transcribe the data. Likewise, if one was to follow the practice of maximizing the use of indigenous site records, use of standard office medical records would be preferred over a form that is study specific and likely to be unfamiliar to site staff.

2. Monitoring:

Can site monitor perform the SDV while patient is @ site or hospitalized? Can CRA review & perform the SDV on the spot at site without violating any confidentiality norms? Can monitor see the patient & asked him whether he is been made aware of trial procedure appropriately & adequately?

Answer: By "SDV" I assume you are referring to "Source Data Verification." SDV generally refers to comparison of information in source documents with information that has been transcribed onto the case report forms. In general, monitors visit clinical trial sites to make these comparisons and to assess the progress of the study.

FDA would not expect sponsors or monitors to have direct contact with study subjects, however, unless there are specific data integrity concerns (for example, the sponsor has reason to believe that some subjects do not, in fact, exist). If, on the other hand, the concern is that subjects have not been adequately or appropriately informed about specific study procedures, or that there are problems with the informed consent process, you should contact the IRB that is responsible for reviewing the study so that the IRB can arrange to "...observe or have a third party observe the consent process and the research," per 21 CFR 56.109(f).

3. Archiving

Can study documents archived @ CRO or Sponsor end incase institute or private clinic does not have adequate space, procedure to retain the documents as per regulatory requirements?

Answer: In general, FDA would expect records that are required to be kept by the clinical investigator to be stored at the clinical investigator's site, and records that are required to be kept by the sponsor to be stored at the sponsor's site. We do understand that situations arise in which a clinical investigator retires or a CRO goes out of business, and needs to find another custodian for the records. In any case, the entity that has the space issue would need to assure that the new custodian is aware of and agrees to comply with FDA's record retention and inspection requirements, particularly in the event that FDA needs to have access to the records. Most institutions, including hospitals, clinics, and universities have standard operating procedures (SOPs) with respect to archiving of essential medical records as well as other sensitive records for which long-term access is necessary. Therefore, it may be beneficial to check with your local institutions to see if they can accommodate your need.

Another thought might be to make electronic copies of the records to reduce the space needed to store the records. FDA's current regulations and guidances on electronic records and signatures permit the interchangeable use of electronic and paper records for the archiving and protection of records, provided that the records are maintained in a manner such that all regulatory requirements are met (e.g., records are maintained for 2 years after the marketing application is approved, as required by 21 CFR 312.57(d), 312.62(c), 812.140(d) or other applicable regulations) and the copies of the required records preserve the content and meaning of the original records.

See Section III.C.5 of FDA's "Guidance for Industry Part 11, Electronic Records; Electronic Signatures- Scope and Application" (www.fda.gov/ohrms/dockets/98fr/5667fnl.pdf), which addresses this, and FDA's "Guidance for Industry Computerized Systems Used in Clinical Investigations" (www.fda.gov/OHRMS/DOCKETS/98fr/04d-0440-gdl0002.pdf), which provides a definition for "certified copy."


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