FDA responses to the questions regarding the process of certifying copies in clinical investigations. Click here to access the full library of FDA responses to GCP questions regarding electronic processes in clinical investigations.
What is the FDA accepted definition of certified copies?
A certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy having all of the same attributes and information as the original (from 2013). Documentation in library.
What are the current regulations regarding the “verified process” of certified copies?
You can define your own process of certifying copies by defining clear SOPs. By having clear SOPs, you can use a certified copy instead of an original. Certification should be done by the person who made the copy, by signing or initialing and dating the copy to show that it meets the requirements of a certified copy (from 2016). Documentation in library.
Who is the person who should verify that the information is original or sign and date the printed copy for a certified copy?
The person who certifies the copy should be the person who actually made the copy. To certify the copy, that person should sign or initial and date the copy to indicate it meets the requirements of a certified copy. It is recommended to have a SOP describing how copies are made, verified, and document and the protocol and delegation logs should outline who can sign off on study documents (from 2015). Documentation in library.
Can you rely on a certified copy that is housed in a system that is not Part 11 compliant?
No (from 2013). Documentation in library.
Is there any recommended time-frame that the site should employ before destroying the original paper records after certified copies have been made?
No. You should ask the sponsor of the studies in which you are converting to electronic records (from 2016). Documentation in library.
Can certified copies be used in place of original paper records during an inspection?
Yes. The FDA allows interchangeable use of electronic and paper records for the archiving and protection of records provided that record keeping and retention requirements are met and that the copy is certified as an accurate representation of the original paper document (from 2016). Documentation in library.
How do we handle receiving “certified copies” of medical records from another party?
Not all copies of study documents need to be signed as certified copies. Certified copies are necessary when original records are copied to a different media for archiving purposes and the originals are destroyed or if you want a copy as a substitute for the original records. In these cases, you should develop clear SOPs to help your staff understand which study documents to certify and the method of certifying the documents (from 2015). Documentation in library.
Can a PDF copy of the original signed version of a Financial Disclosure Form document be given to the sponsor when they are collecting them?
Yes, as long as the copy is certified (from 2016). Documentation in library.
Can electronic copies be used as accurate reproductions of electronic records?
Yes. This is allowed as long as the content and meaning of the original records are preserved and a suitable reader and copying equipment are readily available. Sponsors should certify the electronic copies were produced through a validated process (from 2017). Documentation in library.
Under what circumstances are part 11 requirements not applicable for electronic copies of paper records?
They are not intended to apply to systems that are used to create paper records that are maintained in traditional paper-based systems as long as they capture important metadata that are recorded in the electronic system (from 2017). Documentation in library.
Click here to access the full library. The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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