Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 278

GCP: A Question & Answer Reference Guide
If an investigator retires and is unable to store the study data, he/she must transfer custody to another person who
will accept responsibility for them. The investigator should provide a written notice of this transfer to the sponsor.
This notification should be maintained in the investigator file.
If an investigator is conducting a study in an institution that will otherwise destroy records before the FDAmandated record-retention period, then the investigator must request that the institution make an exception to its
policy to honor the requisite record-maintenance period. In other cases, the sponsor might provide for off-site
storage of the study records. In all cases, an investigator should be reminded not to destroy any study records
without first checking with the sponsor, and record retention requirements should be specified in the protocol.
6.68 Q. Is there any requirement that the investigator must sign and/or approve CRFs (paper or electronic)?
A. According to an informal response from the FDA's office of GCP, the FDA regulations only require a few
signatures. This includes the clinical investigator's signature on the Form 1572 or investigator agreement, a subject's
signature on the informed consent document, and a witness signature on a short-form informed consent form (if
applicable). There has never been an FDA requirement that the investigator sign the case report forms. This is left
to the purview of the study sponsor and is considered a typical sponsor requirement. As a result, if the sponsor
requires a signature then the FDA would consider it necessary. The FDA does expect that the investigator review
all data from his/her site that will be supplied to a sponsor before it is transmitted. A signature is often provided as
documentation that this review was completed.
6.69 Q. Do subject identifiers need to be included on each page of source documents that are submitted to a
sponsor (such as for supporting documentation) for an AE, SAE, or clinical endpoint? Is it acceptable to
only have the identifier on a cover page, or should each page be identified?
A. According to an informal response from the FDA, nothing in the FDA regulations prohibits study sponsors
from collecting identifying information about study subjects. However, sponsors would then be responsible for
maintaining the confidentiality of that data. The HIPAA regulations also do not prohibit the sponsor from collecting
or reviewing documents that may contain the subject's identifiers. Privacy rules only require that the information
be maintained in a confidential way. As a result, sponsors usually collect coded study data for individual subjects
rather than names in their main database for the study. Since documents can become separated from a cover page,
it is advisable to put some kind of identifier on each page of a set of documents. However, the source documents
maintained at the study sites need to be identifiable by individual subject. Study monitors need to be able to verify
the existence of the individual study subjects and that data are correctly attributed to each. FDA's investigators are
instructed to verify source data when conducting inspections of clinical sites in the SOPs for such inspections.
FDA likewise needs to be able to verify this information. FDA does so during bioresearch monitoring (BIMO)
inspections, which can occur both during the conduct of a study and after its completion.
6.70 Q. According to the regulations in 21 CFR 312.64, an investigator is required to provide a final report to
the sponsor after completion of the investigator's participation in the investigation. Do the regulations
actually require the investigator to write a study report relative to their participation?

A. According to an informal response to this question from FDA, all participating clinical investigators
are required by FDA's regulations to submit a final report to the sponsor once the associated clinical study
site has completed their participation in the investigation. In essence, this final report officially closes out
the investigator's participation in the clinical trial and provides the sponsor with the necessary final trial
information for their particular site (i.e., final drug/device accountability, subject data) and knowledge that
they are no longer an active investigator in the associated study. FDA does not specify what information
should be included in this final report or the format for such a report. When the regulations are silent,
sponsors and sites have the flexibility to develop their own practices and procedures that make the most
sense to them. It is likely that the report utilized in closing out the study site with the reviewing IRB would
suffice; however, one should rely on instructions from the sponsor to determine if there is any additional
information that they may request the clinical investigator to include in the final report.

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Good Clinical Practice: A Question & Answer Reference Guide - May 2014

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