Using A Central IRB At Thomas Jefferson University / Hospital Roseann Talarico Associate Director Office…

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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

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<p>Using A Central IRB</p> <p>At Thomas Jefferson University / Hospital</p> <p>Roseann Talarico</p> <p>Associate Director</p> <p>Office of Human Research</p> <p>Joining an Existing Study with Quorum and WIRB Review IRB</p> <p>Complete ePTF and notify ORA of intention to join a study approved by Quorum or WIRB</p> <p>Follow the standard process for creating a new study record in JeffTrial</p> <p>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.</p> <p>If OHR authorizes the submission to proceed, it will issue a signed TJU-Quorum Institutional Cover Page or WIRB Cover Page.</p> <p>Screening Criteria for Jefferson Investigators</p> <p>Applying to Commercial IRBs</p> <p>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:</p> <p>Study is a phase 2, 3, or 4 multi-center, commercially sponsored clinical trial.PI is in good standing with institution in regards to human subjects research compliance (e.g., PI is not currently on probation for violations).PI &amp; research staff have completed appropriate CITI training and are up to date with COI disclosures.</p> <p>4. OHR-1 includes all required signatures.</p> <p>5. PI has history of sound ethical judgment and the ability to manage clinical trials.</p> <p>PI does not have a financial COI with the sponsor of the clinical trial.Submit through JeffTrial and upload to the Portal.</p>

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