Institutional Review Board
FDA responses to questions about the responsibility of the Institutional Review Board in clinical investigations.
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
Is it a requirement to have paper backups of regulatory documents, particularly IRB related documents?
No, you are not required to have paper backups of electronic source data. The FDA allows you to use both electronic and paper records as long as record keeping, retention, and part 11 requirements are met. If the IRB wants to use an electronic scanned copy instead of the paper source data, the electronic system and records must comply with part 11 and the scanned copies must be certified copies (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Does the FDA’s guidance on Electronic Source Data in Clinical Investigations apply to IRBs?
No. IRBs do not capture, review and archive electronic source data in FDA-regulated clinical investigations, or complete eCRFs, so the guidance document would not apply to IRBs (from 2013). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Are there any rules on how to archive IRB records?
No. IRBs must retain their records for at least 3 years after completion of the research, but how they archive the required records is up to the IRB and the institution. If you want to archive records electronically and get rid of the originals, you should develop an SOP for doing so to ensure that the integrity of original records is preserved (from 2014). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Is the IRB documentation that the sponsor receives considered records under predicate rules?
No, unless a sponsor is using an IRB record as a report required under 21 CFR 312.57 (from 2016). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations.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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