Saint Louis University Post Approval Submission Requirements – Central/External IRB Use Type of Submission What to Submit If using an independent central IRB partner (WIRB & Affiliates, Advarra, Quorum) If using NCI CIRB If using StrokeNet IRB or an External IRB (non-partner IRB via an exception) To Central IRB To SLU To NCI-CIRB To SLU To Reviewing IRB To SLU Local Changes to SAF* (personnel, payment, etc.). As required by central Email SLU SAF with changes tracked prior to implementing; new signatures only needed if change in PI As required by NCI-CIRB Change-In-Protocol Form As required by Reviewing IRB Email SLU SAF with changes tracked prior to implementing; new signatures only needed if change in PI Changes to SLU Authorization Form As required by central Email revised Word version of HIPAA with changes tracked As required by NCI-CIRB Change-In-Protocol Form and revised HIPAA with changes tracked and clean copy As required by Reviewing IRB Email revised Word version of HIPAA with changes tracked Protocol Amendments (study-wide changes) or IB Changes Typically submitted by Sponsor unless using as local IRB Nothing Required As required by NCI-CIRB Change-In-Protocol Form Submit as required by Reviewing IRB unless sponsor submits on SLU’s behalf Nothing Required Changes to consent materials/recruitment materials (study-wide, not local language) Typically submitted by Sponsor unless using as local IRB Nothing Required As required by NCI-CIRB Change-In-Protocol Form and revised consents with changes tracked and clean copy As required by Reviewing IRB Nothing Required
Changes to consent materials/recruitment materials impacting local language Submit as required by central unless sponsor submits on SLU’s behalf Email tracked changes for review prior to central IRB; otherwise will review during/after Central As required by NCI-CIRB Change-In-Protocol Form and revised consents with changes tracked and copy Submit as required by Reviewing IRB unless sponsor submits on SLU’s behalf tracked changes for review prior to External IRB; otherwise will review during/after External Continuing Reviews Site progress reports or other form as required by central Email copy of documents submitted to central IRB As required by NCI-CIRB Continuing Review Form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB Unanticipated Problem (Local UP that may or may not also be an SAE) Central IRB form as required by central IRB. Email copy of documents submitted to central IRB As required by NCI-CIRB Information form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB SAEs that are not UPs As required by central Email according to timelines described in . As required by NCI-CIRB Email according to timelines described in . As required by Reviewing IRB Email according to timelines described in . Protocol violations that affect subject rights/safety or data integrity; consenting errors Central IRB form as required by central IRB. Email copy of documents submitted to central IRB As required by NCI-CIRB Information form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB SLU Site Monitor Reports As required by central Email copy to As required by NCI-CIRB Information form As required by Reviewing IRB Email copy to DSMB Reports Typically submitted by Sponsor unless using as local IRB Nothing Required if recommends continuance As required by NCI-CIRB With continuing review reports As required by Reviewing IRB Nothing Required if recommends continuance
Unresolved Subject Complaints, Data Security Incidents, Audit Notifications As required by central Email As required by NCI-CIRB Information form As required by Reviewing IRB Email Study Closures Central IRB form as required by central IRB. Nothing required; courtesy email optional As required by NCI-CIRB Continuing Review/Closure Form As required by Reviewing IRB Email copy of documents submitted to Reviewing IRB