Joining an Existing Study withQuorum Review IRB

  1. Complete ePTF and notify ORA of intention to join a study approved by Quorum.
  2. Follow the standard process for creating a new study record in JeffTrial.
  3. In the Portal, at the “Create an IRB Application” drop-down menu, select “Quorum”, and upload anOHR-1. (Be sure to check off “QuorumReview IRB” at top of OHR-1.)This is the only document you will upload in the Portal. There is no paper submission.
  4. If OHR authorizes the submission to proceed, it will issue a signed TJU-Quorum Institutional Cover Page. This form also verifies that Quorum will insert Jefferson template language into the sponsor’s model consent form. (Jefferson personnel do not need to prepare the consent form.)
  5. Submitting to Quorum:
  1. Login to OnQ WebPortal: Contact to request a Portal account
  1. Submit electronic application by using theSite Information Questionnaire (SIQ)available in the OnQ Web Portal. This form needs to be completed for each study submitted, but non-study specific information will pre-populate fields for subsequent submissions. You also can complete a hard copy version of the SIQ available on main website under “Forms” (F-039)
  1. Upload additional materials as necessary
  1. Submit CV of the PI (Submit once only, unless CV has been updated.)
  1. Quorum analyzes submission and contacts the primary contact listed on the SIQ (See ‘Communication with Quorum’ section of SIQ) if any follow-up is needed before scheduling for review.
  1. Once the submission is ready for review, it will be scheduled for Expedited Review unless there is a Conflict of Interest or any other item that Quorum’s SOPs determine must be sent to full Board. Full Board meetings occur daily so the timeline for either review path is approximately 2 days once a complete submission is received.
  1. Review occurs and afterwards the sponsor’s model consent form with the TJU template language tracked into the Word document will be emailed to the primary site contact and sponsor/CRO contact for review.
  1. Once TJU and the sponsor/CRO approve the changes, the final approval package will post to the Portal. This timeline is a 1-2 day turnaround.

If you have questions or need any assistance with OnQ, please contact Tom Conquergood at Quorum:

Tom Conquergood, CIP

Study Manager

Quorum Review IRB

T | 206-448-4082 x363

F | 206-448-4193

The Quorum Handbook available within the Portal provides guidance for every aspect of working with Quorum.