TMF Update: FDA References on Certified Copies and Original Data


FDA reference original data and certified copy

FDA References for Original Data & Certified Copies in Clinical Trials

As clinical trial professionals try to comply with FDA requirements on electronic records there are a number of documents that are referred to that are hard to find. One is the Compliance Policy Guide # 7150.13 referred to in the definitions section of FDA Guidance Document: Computerized Systems Used in Clinical Investigations (May 2007). It is referenced in the description of “Original Data.” FDA states: “FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provided the copies are identical and have been verified as such.” FDA also has a definition of “Certified Copies” in the same guidance document.

Here are some links that will be of use in researching original data and certified copies:

Compliance Policy Guide 130.400 (equivalent to 7150.13)

Betterchem Link on Compliance Policy Guide

Applied Clinical Trials: CDISC Clinical Research Glossary

Read the Final Guidance from the European Medicines Agency on Electronic Data Capture:

EMA Reflections

Two Important New GCP Documents:

There is a Draft Guidance on Electronic Source Documentation in Clinical Investigations. The comment period is for 90 day (April 4, 2011 ?)

There is a new Final Rule on required elements of Informed Consent. You can read the Federal Register Announcement here that includes FDA comments in the preamble. The exact change in 21 CFR Part 50 is:

“Sec. 50.25 Elements of informed consent.

* * * * *
(c) When seeking informed consent for applicable clinical trials,
as defined in 42 U.S.C. 282(j)(1)(A), the following statement shall be
provided to each clinical trial subject in informed consent documents
and processes. This will notify the clinical trial subject that
clinical trial information has been or will be submitted for inclusion
in the clinical trial registry databank under paragraph (j) of section
402 of the Public Health Service Act. The statement is: “A description
of this clinical trial will be available on
http:[sol][sol]www.ClinicalTrials.gov, as required by U.S. Law. This
Web site will not include information that can identify you. At most,
the Web site will include a summary of the results. You can search this
Web site at any time.”

In news from GxP Perspectives read the updated article on the Form FDA 1572 in:

Applied Clinical Trials “Closing Thought” on FDA 1572

Announcement: TMF Webinar 14 October

ALSO: Please join me on LinkedIn at:

GxP Perspectives LinkedIn Group

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This entry was posted on Wednesday, August 25th, 2010 at 6:42 AM and is filed under GCP. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

4 Responses to TMF Update: FDA References on Certified Copies and Original Data

  1. Reflecting on the Trial Master File, the TMF « Carl's Blog on GxP Stuff says:
    August 25, 2010 at 4:38 PM

    […] UPDATE: FDA Reference Document on Original Data […]

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  2. TMF Reference Model Presented to DIA « Carl's Blog on GxP Stuff says:
    August 31, 2010 at 8:05 AM

    […] GxP Perspective Post on Reference Document […]

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  3. TMF Reference Model Conducts Survey « GxP Perspectives says:
    October 21, 2010 at 10:16 AM

    […] TMF Compliance Documents from FDA […]

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    October 29, 2010 at 9:48 AM

    […] TMF Compliance Documents from FDA […]

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