Overall PI and Lead Study Team checklist

Applies to: SMART IRB SOPs

The Overall PI and Lead Study Team are the hub of a ceded study: they submit everything to the Reviewing IRB and relay everything back to the sites. Their responsibilities under the SMART IRB SOPs (section 3) are collected in the Overall Principal Investigator / Lead Study Team Guidance and Checklist.

In brief, the Lead Study Team: - submits the initial application, site-specific materials, amendments, continuing review, reportable events, and closure to the Reviewing IRB; - distributes approved documents and Reviewing IRB determinations and policies to every site; - collects local considerations, site-specific consent language, personnel information, and COI management plans from relying sites and passes them to the Reviewing IRB; and - keeps the Communication Plan current.

Study-team training and resources: Learning Center for study teams.

See also - Relying Site Investigator checklist - The Communication Plan