Relying Site Investigator checklist

Applies to: SMART IRB SOPs

A Site Investigator whose institution has ceded review still owns the conduct of the study at that site — and has a few duties that exist only because the IRB is external. The Relying Investigator Guidance and Checklist (version March 2025) lists them, drawn from SMART IRB SOPs section 3.

In brief, the Relying Site Investigator and Study Team: - follow the Reviewing IRB's requirements and determinations and the Relying Institution's own obligations under the Agreement; - provide site-specific information — local considerations, consent language, personnel, COI — to the local POC and the Lead Study Team; - report proposed personnel changes and new conflicts to the local POC before they go to the Reviewing IRB; - report reportable events, subject complaints, and research-related injuries promptly through the Lead Study Team; and - provide continuing review information on time.

Many institutions ask investigators to acknowledge these responsibilities when a study is ceded — see Making sure Personnel follow the rules.

See also - Overall PI and Lead Study Team checklist - Making sure Personnel follow the rules