Continuing Review and Closure for Sponsors and CRO's


Home › Sponsors/CROs › Continuing Review and Closure


Regulations require continuing review of the research at least once per year and more frequently if determined necessary by the Board. When Quorum Review IRB is acting as a central Ethics Review Board, Quorum Review IRB will send the sponsor a continuing review packet that will include a copy of the “Continuing Review Report for Protocols” and a copy of the materials provided to sites for periodic site review.

When Quorum Review IRB is not the central Ethics Review Board for a multi-site study, Quorum Review IRB will send the reminder and report form to the investigator who then must forward it on to the sponsor. Sponsors must return the “Continuing Review Report for Protocols” by the due date indicated on the form so that the protocol can be reviewed prior to the site review.

Recommended

F-017 - Continuing Review Report for Protocols
This form is required for study-level Continuing Review.

Guidance

G-040 - Continuing Review Flowchart
Illustration that provides a depiction of the Protocol Continuing Review process.

G-043 - Handbook for Quorum Review IRB (Requires an OnQ Portal Account)
The Handbook provides a guide for using Quorum Review IRB as an ethics review board. It contains policies, procedures, and guidelines to be used in preparing materials for Board review, as well as information on managing ongoing research activities, continuing and periodic review, and closing.

Q.    I received a Site Status Report with the packet for Protocol Continuing Review. Do I need to complete the Site Status Report? >>
No, for central studies Quorum does not require that sponsors or their representatives complete the Site Status Report on behalf of investigators. We include a sample Site Status Update Report and an investigator Periodic Site Review checklist/instruction sheet with the Protocol Continuing Review packet so you are aware of what is expected of sites for periodic review.
Q.    Does the sponsor or sponsor representative need to send Site Status Reports to the investigators to complete? >>
No, Quorum will provide investigators with Site Status Reports and a letter requesting that the report be completed for periodic site review or site closure. These materials are issued to investigators approximately four weeks prior to the Site Status Report due date as cited on the original Notice of Approval or Notice of Re-Approval issued. Additionally, Quorum staff will contact the sponsor or sponsor representative if investigators are unresponsive to our attempts at obtaining a Site Status Report.
Q.    Where can I obtain an electronic copy of my Continuing Review Report for Protocols?  >>
An electronic copy of the Continuing Review Report for Protocols that includes pre-populated study information can be found on the OnQ Portal.
Q.    How do I obtain help completing the Continuing Review Report for Protocols?  >>
Please feel free to contact your Quorum Study Manager if you need assistance in completing specific questions on the Continuing Review Report for Protocols.
Q.    Why are you sending reports requesting Continuing Review as this study has completed? >>
Quorum considers a study closed only after all sites have submitted valid Site Status Reports for closure. If the valid closure notifications from all sites are received prior to the Protocol expiration date, the study can be closed without requiring an additional review. Please contact your Study Manager if you believe your study should be closed.
Q.    What is Quorum’s closing criteria for a site? >>
Quorum Review IRB considers a study closed at a site only if there are no actively enrolled participants and all interventions with participants have ceased. Once our closing criteria have been met, the investigator must provide formal notice of closure by submitting a "Site Status Report for closing".
Q.    How do I close my study? >>
Quorum Review IRB does not consider a protocol closed until all Quorum-approved sites have been closed by the sponsor or the sponsor’s representative, submitted valid “Site Status Reports for Closing," and been administratively closed by Quorum. Once all sites have been closed, Quorum will close the protocol. Quorum does not send sponsors written documentation of study closure.
Q.    If a site is closed, but is being non-responsive, what should I do? >>
In the rare instance that a site is unable to complete the Quorum Review IRB “Site Status Report for Closing" but the sponsor considers the site to be closed, Quorum Review IRB will accept documentation from the sponsor confirming:
  • The site never initiated study activity, or the date of site closure by the sponsor or sponsor representative;
  • That there are no enrolled participants at the site;
  • That the site is no longer collecting data from participants; and
  • The reason for non-responsiveness by the site

Please contact your Quorum Study Manager to assist you with this process.
Q.    Why does Quorum contact me when my expiration date is more than a month from now? >>
Quorum Review IRB requests that the completed Continuing Review Report for Protocols be returned 60 days prior to the approval expiration date to allow adequate time for our staff to analyze the form and request any additional follow-up information if needed. This also allows adequate time for Board review.
Q.    I submitted my Continuing Review Report for Protocols before the report due date. When will it be reviewed? >>
Quorum will ensure your protocol is submitted and reviewed by the Board prior to the protocol expiration date. Once the protocol has been re-approved, Quorum will issue a Sponsor Letter of Reapproval to document the new approval period.
Q.    What if I cannot complete my Continuing Review Report for Protocols by the listed due date? >>
Please contact your Quorum Study Manager if you have having difficulty completing the report by the listed due date. Your Study Manager may be able to authorize additional time to complete and submit the report.
Q.    How do I submit the Continuing Review Report for Protocols? >>
Quorum accepts submissions of Continuing Review Report for Protocolss via the web portal, email (to your Study Manager), or fax. Please remember to submit a signed version of the report.
Q.    What steps does Quorum take to make sure my sites don’t expire? >>
Quorum will send a partially pre-populated “Site Status Report” form to the site approximately two (2) months before the approval expiration date. The completed form should be returned to Quorum Review IRB at least six (6) weeks prior to the approval expiration date to allow adequate time for Board review. Quorum staff follows up with investigators who have not submitted “Site Status Reports” by the due date. Quorum will fax, call, and send an expiration warning letter to the investigator (with a copy to the sponsor) in an effort to assist the investigator and avert an unintended expiration.
Q.    Why does Quorum request a Continuing Review Report for Protocols—isn’t this just for my sites to complete? >>
At the time of initial review of research, the Board establishes an approval period for the protocol. Regulations require continuing review of the research at least once per year and more frequently if determined necessary by the Board. The Continuing Review Report for Protocols is meant to capture information for the study as a whole, including information that has occurred at all Quorum and non-Quorum sites. Each investigator is also expected to complete a Site Status Report for periodic site review to report information that has occurred at their particular site.
Q.    My Protocol Continuing Report due date has passed, but I plan to close the study prior to the expiration date. How do I close as many people as possible and save money while still being compliant? >>
Quorum makes every effort to ensure protocols are reviewed prior to the expiration date. If you are attempting to close a study prior to the protocol expiration date, please work with your Quorum Study Manager regarding the timing of protocol closure.
Q.    Do I have to get sites that never had study drug delivered/never enrolled participants to complete a closing report? >>
Quorum prefers written documentation from the investigator in order to close a site. In rare circumstances, if a site is being unresponsive, Quorum Review IRB will accept documentation from the sponsor confirming:
  • The site never initiated study activity
  • That there are no enrolled participants at the site
  • The reason for non-responsiveness by the site

Please contact your Quorum Study Manager to assist you with this process.