After the reliance determination

Applies to: Reliance System

Once the determination letter is issued, the Reviewing IRB reviews and oversees the study through its own processes and systems. The Reliance System is not an IRB submission system.

What you get. A determination letter for each site that relied, downloadable from the request. Keep it with your study records; relying sites typically file it in their local eIRB system. If a Site Investigator later changes, the PDF updates automatically.

What to do next - Lead Study Team: submit the protocol, consent templates, and site-specific materials to the Reviewing IRB following its submission process — the reliance request does not do this for you. - Relying Site Study Teams: provide your site-specific consent language, local considerations, and personnel information to the Lead Study Team (or as your Communication Plan specifies). - Everyone: agree on who communicates what — the Communication Plan template is designed for this — and, if your institutions are using any flexible provisions, record them in the Implementation Checklist.

Keeping the request current. The request stays active in the System for the life of the study. Study teams and Site Admins can update site investigators and research personnel at any time, Reviewing IRB staff and the Overall PI's home-institution personnel can upload updated protocol narratives and consent forms, and new sites can be added. Updating the request does not replace the Reviewing IRB's amendment process — amendments, continuing review, and reportable events still go to the Reviewing IRB. See Edit a request.

See also - The Communication Plan - Amendments and personnel changes - Edit a request