Using A Central IRB At Thomas Jefferson University / Hospital Roseann Talarico Associate Director Office of Human Research.

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Presentation transcript:

Using A Central IRB At Thomas Jefferson University / Hospital Roseann Talarico Associate Director Office of Human Research

Joining an Existing Study with Quorum and WIRB Review IRB

 Complete ePTF and notify ORA of intention to join a study approved by Quorum or WIRB  Follow the standard process for creating a new study record in JeffTrial

 In the Portal, at the ‘Create an IRB Application’ drop-down menu, select ‘Quorum or WIRB’, and upload an OHR-1. (Be sure to check off ‘Quorum Review IRB or Western IRB (WIRB)’ at the top of the OHR-1.) This is the only document you will upload in the Portal. There is no paper submission.  If OHR authorizes the submission to proceed, it will issue a signed TJU-Quorum Institutional Cover Page or WIRB Cover Page.

Screening Criteria for Jefferson Investigators Applying to Commercial IRBs

The Office of Human Research will apply the following criteria when determining whether an investigator may apply to join a study approved by a commercial IRB: 1. Study is a phase 2, 3, or 4 multi- center, commercially sponsored clinical trial. 2. PI is in good standing with institution in regards to human subjects research compliance (e.g., PI is not currently on probation for violations). 3. PI & research staff have completed appropriate CITI training and are up to date with COI disclosures.

4. OHR-1 includes all required signatures. 5. PI has history of sound ethical judgment and the ability to manage clinical trials. 6.PI does not have a financial COI with the sponsor of the clinical trial. 7.Submit through JeffTrial and upload to the Portal.