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What are US FDA expectations about archival of documents in electronic format?
Dr Anil Biswas
The US FDA permits the interchangeable use of electronic and paper records for the archiving and protection of records provided that record keeping, and retention requirements are met. As per US FDA regulations It is permissible to transfer archival records to an electronic medium. If the sponsor intends to substitute paper copies (destroy the original) with electronic copy, they should comply with provisions of 21 CFR 11, which covers the use of electronic records and signatures used to meet an FDA record keeping requirement. The process for copying and retrieval would have to meet expectations for availability and being able to generate electronic copies suitable for FDA review and further copying. Burning a CD at the end of the study is an acceptable method to archive study related documents. A company should ensure that whatever media it uses does so in a manner that preserves the integrity of the original data/information. If a certified copy will serve as a substitute for the original, it would be desirable that the company has a standard operating procedure for describing how such copies would be made, verified, and documented. This procedure should be developed and approved by the sponsor.
Are electronic signatures regulatory documents for clinical trials acceptable to health authorities?
Prakash Diwakar
US FDA accepts electronic signatures regulatory documents for clinical trials if they follow 21 CFR Part 11FDA's regulation addressing electronic records and signatures.
Some of pitfalls to avoid are:
• Not having a secure process to authenticate signers
• Not programming timeouts and logouts necessitating the re-entry of a password to gain access to the system
• Not linking electronic signatures to the document signed
• Not implementing safeguards to immediately detect and report unauthorized attempts to use signatures
• Not having a process for an emergency to allow a person to “authorize” another person to use his/her signature
• Not having an audit trail to track when the document was signed and who signed it
• Not having the ability to have multiple signers for a document
Can an investigator site archive records outside the institution?
Dr Deepak Chandwani
The investigator can archive records at a location outside the institution. The sponsor can assist the investigator in legal contract with the archival company and provide the budget for this process. The investigator should notify the sponsor regarding the details.
In case of a regulatory inspection, the inspector would expect to see the original records or certified copies of such. Therefore, the stored records be made available for inspection when needed for clinical trials of investigational drugs and/or biologics or investigational devices. There should be a written legal contracts between the research site and the storage facility specifying the conditions for archival and requirements for delivery to the site when needed. The investigator site should have written standard operating procedures for storage of the records and for tracking who is able to access them, so that the regulatory agency can be assured that the records have not been tampered with or altered and that confidentiality of information has been maintained throughout the duration of the transfer and storage.
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