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Quorum Review IRB
Quorum Review IRB (Quorum) is a commercial IRB under contract with Saint Louis University (SLU) to review eligible industry-sponsored, multi-center clinical trials.
Can I use Quorum?
A clinical trial may be eligible for submission to Quorum if it meets all of the following criteria:
• Is an industry-sponsored, multi-center clinical trial
• Has already been pre-reviewed or approved by Quorum (submitted by sponsor or another site)
• Procedures take place at an authorized site (SLU, SLU Hospital, and SSM sites)
• Is not an HUD
• SLU investigators do not hold the IND or IDE
• Study was not previously reviewed by SLU IRB
NOTE: The PI of the study may need to have recent completion of CITI or comparable training (potentially including investigator meetings) in order to submit to Quorum; otherwise, approval of the SLU site application may be delayed pending documentation of additional training certificates.
How do I get access to Quorum's system?
Investigators and regulatory support staff planning to submit to Quorum should request access to the OnQ Portal system (Quorum's electronic submission system) as soon as possible. This can be done on Quorum's website: http://www.quorumreview.com/.
What steps do I take to submit to Quorum?
Step 1: Confirm that a study is eligible for Quorum review. Contact Quorum's Site Support at 206-448-4082 (Option 1) to determine whether Quorum has the protocol (ask whether there is a Quorum protocol ID for that sponsor protocol). If they have it, then review SLU eligibility criteria, above, to ensure submission to Quorum is allowable. Investigators are encouraged to consult with the SLU IRB Office to make eligibility determinations. Inquiries can be sent to email@example.com or call the IRB office at 314-977-7744. Note: it is recommended that you identify whether Quorum is acting as a "central IRB" for the study or a "local IRB" for the study. If acting as a central, it is more probable that the sponsor/CRO will be willing to submit post-approval materials (such as protocol amendments) on behalf of the SLU site.
Step 2a: Investigator begins local processes necessary for all clinical trials at SLU. To get approval for submission to Quorum, the Clinical Trial Agreement (CTA) must be agreed upon and other necessary financial requirements must be met (for details, contact the Clinical Trials Office at 977-6335 or firstname.lastname@example.org). Note that the signed 1572 and signed SSM Health SLUH application must be submitted with the CTA for the SLUH review process, if applicable.
When preparing study budgets, IRB fees should be included. There is a one-time SLU administrative review fee of $750 for Quorum studies which will be billed to the research department with the expectation that the sponsor ultimately provides payment. Quorum review fees are additional and available here (note: SLU may not have the most current versions.) Quorum will bill the sponsor directly if the sponsor allows it. Some sponsors require all billing to go through the SLU research division. If sponsors do not pay Quorum invoices in a timely manner, Quorum will bill the SLU department for payment.
NOTE: All investigators listed on the study must also have annual disclosures on file with the conflict of interest office and must have completed training in human subjects research protections. If the study involves non-standard of care radioactive materials, the SLU RSC will need to review the study first. See the RSC webpage for additional instructions.
Step 2b: Prepare the Central IRB Submission Authorization Form (SLU form) along with required attachments and submit to the SLU IRB office. The SLU IRB office facilitates the SLU administrative review process; submission to Quorum cannot occur until the Submission Authorization Form is approved. This process may occur concurrently with work on the CTA and financial arrangements.
Note that the following will be required for the SLU Administrative Review Process:
• Completed Central IRB Submission Authorization Form (SLU form)
• Completed Quorum Site Information Questionnaire (the Quorum application)
- This electronic Quorum form is completed in Quorum's OnQ Portal system and should be saved as a PDF and printed for submission to SLU IRB prior to submitting the application to Quorum.
• Sponsor's protocol, any recruitment material, Investigator's Brochure
• Consent or Assent Documents previously approved by Quorum (Quorum/sponsor can provide copy)
- SLU investigators will not be responsible for generating the SLU consents/assents. SLU has given Quorum required language for SLU consents, and any protocol specific language will be provided to Quorum on our institutional cover page.
• HIPAA Documents
- SLU investigators will be responsible for drafting HIPAA Authorization Forms. Please use the standard SLU template HIPAA Authorization Form when preparing this document, and be sure to add the central IRB to the list of PHI recipients.
The SLU IRB office will route materials to other SLU offices as needed (Clinical Trials Office, General Counsel, Radiation Safety, Biological Safety, Conflict of Interest, etc.) for review. However, if investigators are aware that approvals will be necessary from other offices or committees, they are encouraged to work with these groups directly as soon as possible to expedite processes.
If issues arise during SLU Administrative Review, the PI or study contact will be contacted and revisions may be requested.
Step 3: Submission to Quorum. Once SLU authorization (the signed Central IRB Submission Authorization Form and signed Institutional Cover Page) is received, the investigator can proceed with submission of materials directly to Quorum. The Institutional Cover Page should be included with the Quorum submission, along with the SLU approved HIPAA Authorization form. The Quorum website and OnQ Portal system training (available once log into system) can be referenced for assistance in submitting materials.
Step 4: Quorum Review. Quorum will contact the PI/Admin Contact directly with questions about the submission, and with determinations of approval or disapproval. Often, Quorum issues conditional approval with redlined versions of consent documents (with institutional language incorporated) for the institution (IRB), site (PI or designee) and sponsor to approve or to outline any requested revisions. The IRB Office and PI/Admin Contact collaborate on that consent approval process should it be needed. Once fully approved, all approval documents will be sent to the investigator. The SLU IRB Office should be copied on approval correspondence, but asks the PI/Admin Contact to ensure IRB Office receives notice.
Step 5: Do not commence research until all institutional approvals are in place. Make sure that all institutional approvals and the clinical trial agreement are in place prior to beginning the study. IRB-stamped HIPAA Authorizations will be provided to the research team from the SLU IRB Office once central IRB approval is in place and consent materials have been accepted by the institution.
What do I need to do after approval?
Quorum and Saint Louis University each have responsibilities for overseeing this research, thus there are reporting requirements to both organizations.
SUBMISSIONS TO QUORUM AFTER INITIAL APPROVAL:
Investigators should submit subsequent protocol documents, events or activities directly to Quorum according to guidelines provided by Quorum. Submissions to Quorum include:
• Change Requests
• Site Status Updates*
• Unanticipated Problems (may or may not also be an SAE)*
• Protocol Violations/Deviations that affect risk/benefit ratio, subject rights/safety, or study integrity*
• Closure Notifications
• Other submissions required by Quorum
Some sponsors/CROs will submit material on behalf of the SLU site; otherwise, the SLU research team is responsible.
*To fulfill monitoring responsibilities, copies of site status updates (continuing reviews), safety event reports and site monitor reports should also be submitted to email@example.com.
SUBMISSIONS TO SLU IRB AFTER INITIAL APPROVAL:
To ensure appropriate institutional oversight of research activities, investigators should directly notify SLU IRB of the following events on Quorum protocols:
• SAEs that are not UPs (and thus not reported to Quorum)*
• Subject complaints not easily resolved by the research team*
• Breaches of confidentiality*
• Audit notifications*
• Monitor reports if not submitted to Quorum*
- Copies of site status reports (continuing reviews), site monitor and safety event reports (not DSMB reports)**
- Changes to local HIPAA Authorization form or changes in research team personnel**
*Submit the above items in accordance with definitions and submission requirements detailed in the SLU IRB Requirements for Reporting Events Relating to Subjects/Subject Safety. SLU IRB will route information related to these reports to university officials as needed for review; however, investigators should also contact General Counsel and/or the SLU Privacy Officer when appropriate.
**Promptly submit these items to firstname.lastname@example.org. Changes to the local HIPAA Authorization form or research personnel should be submitted with tracked changes and approved prior to implementation.
Who should I contact if I have questions?
Questions about the Quorum process and SLU requirements should go to Emily Harrison at email@example.com or 314-977-7741.
Questions regarding Quorum submission and reporting requirements are best handled by contacting Quorum directly, either by calling Site Support at 206-448-4082 or the SLU Quorum Account Manager, Rachael Birge, at 206-902-3338, or by visiting http://www.quorumreview.com/sites/initial-submission/.