Saint Louis University Post Approval Submission Requirements Central/External IRB Use – What to Submit If using an independent central IRB partner If using NCI CIRB If using StrokeNet IRB or an External IRB (WIRB & Affiliates, Advarra, Quorum) (non-partner IRB via an exception) Type of Submission To Central IRB To SLU To NCI-CIRB To SLU To Reviewing IRB To SLU Local Changes to SAF* As required by Email SLU SAF with As required by Change-In-Protocol As required by Email SLU SAF with (personnel, payment, central changes tracked prior NCI-CIRB Form Reviewing IRB changes tracked prior etc.). to implementing; to implementing; new signatures only new signatures only needed if change in needed if change in PI PI Changes to SLU As required by Email revised Word As required by Change-In-Protocol As required by Email revised Word Authorization Form central version of HIPAA with NCI-CIRB Form and revised version of HIPAA with Reviewing IRB changes tracked HIPAA with changes changes tracked tracked and clean copy Protocol Amendments Typically submitted As required by Change-In-Protocol Submit as required (study-wide changes) by Sponsor unless Nothing Required NCI-CIRB Form Nothing Required by Reviewing IRB or IB Changes using as local IRB unless sponsor submits on SLU’s behalf Changes to consent Typically submitted As required by Change-In-Protocol As required by materials/recruitment by Sponsor unless Nothing Required NCI-CIRB Form and revised Nothing Required Reviewing IRB materials (study-wide, using as local IRB consents with not local language) changes tracked and clean copy
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
central_irb_post_approval_requirements.docx