Continuing review and lapses

Applies to: Agreement V3.0 · SMART IRB SOPs

The Reviewing IRB conducts continuing review for all relying sites. The Lead Study Team collects each site's information and submits it; Relying Site Study Teams are responsible for providing theirs on time.

If one site's information arrives late, IRB approval expires for that site only. Sites that submitted on time are re-approved and notified. The Reviewing IRB notifies the Site Investigator and Point of Contact at the lapsed institution separately, and notifies the Overall PI and Lead Study Team of the lapse and any corrective action plan. A lapse at one site does not affect approval at others.

The Harmonization Steering Committee's Single IRB Continuing Review Process recommendations describe common workflows.

See also - Amendments and personnel changes - The Communication Plan