FDA has released Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval. This document gives specific (yet draft) guidance on the process for ensuring continued IRB review once a trial is under way.

According to outsourcing-pharma.com (Rise of multi-site trials prompts FDA guidance on IRBs), the FDA places the assurance of continued IRB review with the sponsor because of their “unique position of having information across all study sites, interim assessments by DMCs and safety information”.

Additionally, the document seems to provide explicit approval to use centralized IRBs in managing multi-site trials (a common practice by most sponsors and CROs).

Sponsors who have embraced eClinical technology for collecting and managing data and documents should miss a beat. But, those of you (sponsors) without real-time access to study and site performance data (enrollment, monitoring, safety, etc) and documents may need some assistance.

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