Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 136

GCP: A Question & Answer Reference Guide
the FDA had been of the study's discontinuation, the site would have been required to maintain the study records
for two years).
The 483 citation noted: " You failed to retain case report forms (CRFs) and source documents (i.e., the notes
you used to fill out case report forms) that are necessary for the verification of data integrity and compliance and
compliance of study activities with federal regulations for the marketing application of the investigational drug, "
the FDA follow-up warning letter stated: " You are required to keep these study-related records for two years
following the approval of a marketing application for the study drug for the indication that was the subject of your
investigation, or until the study was discontinued and FDA was notified. Your study terminated..., but because a
marketing application has not yet been approved or not approved for... the indication . . ., and because FDA has
not been notified that the study was discontinued, you were required to retain your study records.
We acknowledge your response to the FDA Form 483 in which you agreed that the photocopied case report
forms (CRFs) could not be found. You stated that your staff was able to find the subjects' medical records. However,
these medical records are not an adequate substitute for the CRFs and other source documents, which you were
required to retain per 312.62(c). "
5.28 Q. A site is using an Electronic Medical Record (EMR) system to upload all study related documents.
However after documentation upload they no longer keep the original/ wet-ink documentation including
signed ICFs, they just shred them. There is a Site Manual detailing this process. Could you please let me
know if it is acceptable from FDA's perspective to have such a practice at a site?
A. The FDA responded to this question in 2018 with the following: Retention period is dependent on whether
the data will be used to support a marketing application with FDA. The sponsor is usually the only party totally
knowledgeable about the status of its investigational product (e.g., whether it has been approved for marketing,
whether the sponsor no longer intends to seek marketing approval, etc.). Therefore, it is best to check with the
study sponsor regarding the status of the investigational product and the need to retain the study records. You
should check with each of the study sponsors before discarding any study files. FDA regulations do not specifically
address what documents need to be maintained at time of destruction.
That said, In the situation you describe and based on information from FDA guidance on the subject, it appears
that destruction of the hard copy is acceptable. Under 21 CFR 312.62, 511.1(b)(7)(ii) and 812.140, the clinical
investigator must retain records required to be maintained under part 312, § 511.1(b), and part 812, for a period of
time specified in these regulations. This requirement applies to the retention of the original source document, or a
copy of the source document.
Also, please see: " Guidance for Industry: Part 11, Electronic Records; Electronic Signatures ― Scope and
Application " , at https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/
ucm563785.pdf.
Again, FDA's current regulations and guidance's 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
approval of the investigational drug product as required by 21 CFR 56) and the copies of 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 " (link above), which addresses this, and FDA's " Guidance for Industry Computerized Systems
Used in Clinical Investigations " (link above), which provides a definition for " certified copy. " Please see also FDA's
guidance on electronic source data in clinical investigations: https://www.fda.gov/downloads/drugs/guidances/
ucm328691.pdf.
5.29 Q. Does the FDA have guidelines to follow or parameters that can be followed to ensure safe storage and
retrieval of scanned documents for source documentation?
A. By digitizing paper source documents, you are essentially creating certified copies of those source documents.
FDA's regulations do not define " certified copy " , however the term is defined in the E6 (R2) Good Clinical Practice:
Integrated Addendum to ICH E6 (R1) (recognized as official FDA guidance) as " a copy (irrespective of the type
of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a
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https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm563785.pdf. https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm563785.pdf. https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf https://www.fda.gov/downloads/drugs/guidances/ucm328691.pdf

Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

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