Good Clinical Practice: A Question & Answer Reference Guide - May 2014 - 256

GCP: A Question & Answer Reference Guide
6.22 Q. For a recent clinical study, the sponsor had developed forms to help capture study information. While
the sponsor called these forms "source documents," the investigator kept those records in the front jacket
of the subject study binder. The sponsor claimed that the forms helped the monitor easily compare the
information to the case report forms. Obviously, data were also collected in the medical chart for the
patient, and some information was repeated in the chart (e.g., blood pressure, pulse, date of visit). Are
these forms considered source documents? If they are, shouldn't these forms be kept with the medical
records, not in the study binder? Or does it matter?
A. In an informal response to this question, the FDA noted that, "there is no problem with a sponsor providing
worksheets to assist the site staff in either recording original data directly on the form (in which case they would
be source documents) or pulling together data from several sources and transcribing onto the worksheets (in
which case they are not source documents). I find it unusual that the sponsor would label these forms as source
documents. They are only source documents if they represent the original records of the observation. It really
doesn't matter where the records are stored as much as it matters if the monitors understand whether they represent
source documents or not."
6.23 Q. Does the FDA provide guidance on the minimum amount of information an investigator should
maintain for subjects who are screened for their eligibility for a clinical trial, in particular for those who
fail screening?
A. In a recent informal response, a staffer in the FDA's Good Clinical Practice Program stated, "I am not aware
of any FDA guidance that specifically addresses what information an investigator should maintain on individuals
who fail screening. The ICH E6 Good Clinical Practice Consolidated Guidance . . ., an FDA endorsed guidance
document, includes screening logs in the list of essential documents to permit evaluation of the conduct of a trial
(see section 8.3.20); but FDA regulations do not specifically identify such logs . . . If screening logs are used, they
are considered study related documents and need to be maintained in accordance with 21 CFR 312.62(c) for drug
and biologic studies . . .
"In general, the information maintained on individuals screened for a study should be sufficient to demonstrate
that the study screening was appropriately conducted per the investigational plan. I believe the information needed
to demonstrate compliance with the investigational plan may depend on the specific study. If screening is based
solely on procedures and tests that are the standard of care for such patients (that is, would be performed whether
or not study entry was contemplated, such as for diagnosis or treatment of a disease or medical condition), then
specific records on screen failures may not be needed unless the sponsor requires such records (in which case you
should contact the study sponsor to determine the minimum information needed). In the case where screening
involves procedures/tests that are performed solely to determine study eligibility, however, I believe records need
to be maintained because these activities are directly related to the research. At a minimum, the records should
include signed and dated consent forms for the screening procedures/tests, the results of those procedures/tests and
any other documentation, such as physician's or nurse's notes, documenting the reason for screening failure. Of
course, for individuals who pass screening, records demonstrating that the screening criteria are met would be part
of the case histories required to be maintained for the study."
6.24 Q. What is the status of the data and information collected on a clinical trial participant, and the clinical
investigator's access to that information, if the participant subsequently withdraws from the study at a
particular point? Is the previously collected information and data considered part of the clinical study
database following the withdrawal, or can the subject withdraw not only his/her further participation in
the study but the going forward use of the previously collected data and information as well?
A. The FDA used an October 2008 guidance titled, "Data Retention When Subjects Withdraw from FDA-Regulated
Clinical Trials," to restate what the agency called its "long-standing policy that already-accrued data, relating to
individuals who cease participating in a study, are to be maintained as part of the study data." The guidance points out
that all key parties involved in the clinical research process-including sponsors/monitors, clinical investigators, and
the FDA-must continue to have access to a subject's study data that were obtained prior to the subject's withdrawal
from the study. Although the FDA said that this has been a long-standing agency policy, it issued the new guidance for
"immediate implementation, to prevent the potential loss of important clinical trial data."
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Good Clinical Practice: A Question & Answer Reference Guide - May 2014

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