FDA Guidance- Converting Paper Files to Electronic


converting paper to electronic FDA guidance

Need to Convert Paper Files?

Converting paper files to electronic records is a practice allowed by FDA and other regulatory agencies. This question is frequently asked by those responsible for maintaining records and the Trial Master File (TMF). Workers who are trying to cut down on the massive amount of storage space needed to comply with FDA record retention policies, an important issue for GCP compliance. However, not only is it allowable, FDA actually tells you how to do it in relatively understandable English. The key guidance document you will need as a reference is:

Guidance for Industry: Part 11; Electronic Records; Electronic Signatures- Scope and Application (August 2003).”

Here is what the agency has to say:

4. Copies of Records

The Agency intends to exercise enforcement discretion with regard to specific part 11 requirements for generating copies of records (§ 11.10 (b) and any corresponding requirement in §11.30). You should provide an investigator with reasonable and useful access to records during an inspection. All records held by you are subject to inspection in accordance with predicate rules (e.g., §§ 211.180(c), (d), and 108.35(c)(3)(ii)). We recommend that you supply copies of electronic records by:

• Producing copies of records held in common portable formats when records are maintained in these formats

• Using established automated conversion or export methods, where available, to make copies in a more common format (examples of such formats include, but are not limited to, PDF, XML, or SGML)

In each case, we recommend that the copying process used produces copies that preserve the content and meaning of the record. If you have the ability to search, sort, or trend part 11 records, copies given to the Agency should provide the same capability if it is reasonable and technically feasible. You should allow inspection, review, and copying of records in a human readable form at your site using your hardware and following your established procedures and techniques for accessing records.”

I was able to get this information from FDA’s excellent resource, “GCP Questions.” There is a link under FDA Stuff, scroll down beneath the Blogroll on the right, as: FDA Answers to GCP Inquiries. That’s also where you will find the Scope and Application for Part 11 link to the FDA Guidance Document.

I would make a very strong recommendation that before you start converting paper files to electronic ones that you develop a standard operating procedure (SOP) for how you are going to do it. Your files are your story of how a clinical trial was conducted. You want to convert files the right way each and every time.

UPDATE 6 January 2011: 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.”

FDA Guidance on converting paper files to electronic

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