Ask the Experts: Certifying and Maintaining Copies of Original Source Documents
The FDA’s Office of Good Clinical Practice (OGCP) receives letters from clinical trial professionals inquiring about agency policy on a variety of topics. Following are two inquiries and the OGCP’s answers.
Question: Our site recently switched to electronic medical records and we need to come up with an SOP on certified copies of source documents. Once the study is closed, we would like to destroy the original source with wet ink. According to our clinical trial management system, we are allowed to do so as long as we have an SOP in place stating this. Can you provide me with information to support this?
Answer: The term “certified copy” is defined in FDA’s Final Guidance — Computerized Systems Used in Clinical Investigations as: “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” (https://bit.ly/3i79yHn).
The use of certified copies generally applies to situations where original records are copied to a different media for archiving purposes and the originals are destroyed. However, if it is decided to have a certified copy substitute for the original, it would be desirable to have an SOP describing how such copies would be made, verified and documented.
The person who certifies the copy as an accurate and complete representation of the original, having all of the same attributes and information, should be the same person who actually made the copy from the original. Certification should be accomplished by having the person who makes the copy sign or initial and date the copy to indicate it meets the requirements of a certified copy as described above. This should be described in the SOP and can be accomplished by initialing and dating each copy or by initialing and dating a document certifying copies in bulk.
The SOP should describe the procedure, whichever method is used. (There are many ways to accomplish this, and the procedures described above are only suggested examples.)
Q: A question has arisen during a recent monitoring visit regarding certified copies of paper records. Several times study information is collected on paper forms. It is then certified copied using a process that is described in our SOPs that the certified copy is an exact original of the paper record and then uploaded into our electronic files. We were recently instructed that the original paper records should not be destroyed but rather should be kept in addition to our certified copy that was uploaded to our electronic files. Once the document has been certified copied, can the original paper form be destroyed?
Also, we collect data using a tablet rather than paper. A handwritten signature is collected on the tablet with the use of a stylus. The study data is then maintained in an FDA Part 11 compliant system. Is the handwritten signature equivalent to one collected on paper?
A: Our office is frequently asked whether investigators/sites may store/archive study records by converting paper documents into an electronic format; in essence, creating certified copies of source documents. FDA’s draft guidance for industry entitled “Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 — Questions and Answers” (https://bit.ly/3s6UgXz) provides recommendations to sponsors, clinical investigators, IRBs, CROs and other interested parties on the use of electronic records and electronic signatures under Part 11 in clinical investigations of medical products. Appendix II of this draft guidance defines a certified copy as:
“A copy (paper or electronic) 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.”
Can sponsors and other regulated entities use and retain electronic copies of source documents in place of the original paper source documents?
Yes. FDA permits the interchangeable use of electronic records and paper records for the archiving and protection of records, provided that recordkeeping and retention requirements are met (see 21 CFR 56.115, 312.57, 312.62 and 812.140). If the sponsor or other regulated entity intends to use an electronic copy in place of the paper source data (i.e., intends to destroy the paper source data), then Part 11 regulations would apply to the electronic system used to create the copy (see sections 11.10 and 11.30). A process should be in place to certify that the electronic copy is an accurate representation of the original paper document. The copy of the original record should be verified as having all of the same attributes and information as the original record and certified as indicated by a dated signature. Sponsors and other regulated entities should have written procedures to ensure consistency in the certification process.
In addition, some electronic copies vary in terms of their ability to be modified. For electronic copies in which the records are modifiable, it would be important to have audit trails in place to ensure the trustworthiness and reliability of the electronic copy. Also, as noted earlier, 21 CFR 11.10 and 11.30 require physical, logical and procedural controls designed to ensure the authenticity and integrity of electronic records.
Although this guidance is still in draft form, the Office of Good Clinical Practice has responded to many public inquiries about scanning paper consent forms to an electronic format in this manner. As noted in the draft guidance, if it is decided to have a certified copy substitute for the original, a process should be in place to certify that the electronic copy is an accurate representation of the original paper document (e.g., an SOP) describing how such copies would be made, verified and documented.
Certification should be accomplished by having the person who makes the copy, sign or initial and date the copy to indicate it meets the requirements of a certified copy as described above. The process should be described in an SOP and can be accomplished by initialing and dating each copy, or by initialing and dating a document certifying copies in bulk. Whichever method is used, the SOP should describe the procedure.
Appendix I of the draft guidance document also has some good references to other guidance documents with applicable recommendations that may be helpful to your colleagues.
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; however, to be sure you should consult the sponsor.
In your second scenario, because you are using a Part 11 compliant system on the tablet, it appears that the signature would be acceptable. Again, please review the guidance referenced above.