Cont. Review and Closing - Minimal Risk Studies


Home › Sites › Periodic Review and Closure › Minimal Risk Studies


Periodic Site Review

At the time of initial review of research, the Board establishes an approval period for an approved study. Regulations require Continuing Review of the research at least once per year and more frequently if determined necessary by the Board. Approval to investigators to conduct research at their particular site(s) is tied to the protocol approval. The expiration date of an investigator’s Board approval will be noted on the "Notice of Approval", and "Site Status Reports." Reminders about the Site Status Report due date will be noted on subsequent "Amended Approvals."

In order for Board approval of a study to be extended beyond the current approval period’s expiration date, the investigator must submit a completed "Qualified Minimal Risk Site Status Report for Periodic Site Review" for the site. 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.

Site Closure

Quorum Review IRB considers a study closed at a site only if there are no actively enrolled participants, all interventions with participants have ceased, and the sponsor/CRO has closed the study site. Please note that being "closed to enrollment" does not meet Quorum Review IRB’s definition of study closure.

Once all participants have completed a study and all interventions with participants have ceased, Quorum Review IRB considers the date of study closure to be the date on which a representative of the sponsor administratively closes the study at the research site. Quorum Review IRB will not accept "Qualified Minimal Risk Site Status Reports for Site Closure" that are received before the date of study closure.

Quorum Review IRB will send the investigator and sponsor a letter of acknowledgement of site closure. Although Quorum Review IRB will accept further information submitted for a closed research site, no approvals of additions or changes to research activities will be issued.

Required

F-048 - Reopen Request Form for Sites
Use this form for all sites that closed in error in order to reopen a study site and resume IRB oversight and research activity.

F-050 - Qualified Minimal Risk Site Status Report for Periodic Site Review
This form is needed for periodic site review (formerly known as site continuing review) for Qualified Minimal Risk studies.

F-051 - Qualified Minimal Risk Site Status Report for Site Closure
This form is needed for site closure for Qualified Minimal Risk studies.

Guidance

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.    Does Quorum have a separate form for sites in Qualified Minimal Risk studies?
Yes. Quorum has a form called the Qualified Minimal Risk Site Status Report for Periodic Site Review. This form is available on Quorum’s website. Quorum will also send a copy of the Qualified Minimal Risk Site Status Report for Periodic Site Review prior to the site's anniversary.
Q.    My site is closing. Does Quorum have a separate site closure form for Qualified Minimal Risk studies? >>
There is a site closure form that is designated for QMR studies, called the Qualified Minimal Risk Site Status Report for Site Closure. This form is available on Quorum’s website.
Q.    What is Periodic Site Review? >>
Periodic Site Review is a review that occurs prior to your study expiration date. If you plan to continue to conduct your study after your expiration date listed on your Notice of Approval (or Notice of Re-Approval), then you will need to submit a Site Status Report for periodic site review.
Q.    When does Quorum consider a site to be closed? >>
Quorum considers a site to be closed when all of the following criteria have been satisfied:
  • You have no enrolled participants.
  • You are no longer collecting data from participants.
  • Your sponsor or the sponsor’s representative considers you closed.

If your site does not meet all of these requirements, Quorum does not consider you closed. If you do not meet these requirements but your sponsor does consider you closed, please contact Quorum for further guidance on this matter.
Q.    How do I know if my site should close or go through Periodic Site Review? >>
If you meet the requirements for closing (see criteria above), you should complete a Site Status Report for Closing and submit it to Quorum. If you do not meet all the requirements for closing, and will not meet them before the expiration date listed on your Notice of Approval (or Notice of Re-Approval), then you will need to submit a Site Status Report for periodic site review. Please note that if a Site Status Report is not received by the IRB approval expiration date, IRB approval to conduct your study will expire. Be advised, conducting research activities without IRB approval is a violation of federal regulations. Furthermore, failure to provide a Site Status Report for Periodic Site Review or Closing may lead to a finding of serious or continuing noncompliance which requires notification to the U.S. Food and Drug Administration.
Q.    What if my site is scheduled to close before the IRB expiration date? >>
If you are closed, or planning to close before your IRB expiration date, you should complete a Site Status Report for closure and submit it to Quorum. If you don’t expect to close until after your expiration date, you should remain open and submit a Site Status Report for periodic site review. If the sponsor or sponsor representative will be closing your site a couple of days prior or on your expiration date, Quorum suggests you send in a Site Status Report for Periodic Site Review to prevent site expiration.

Please note that if a Site Status Report is not received by the IRB approval expiration date, IRB approval to conduct your study will expire. Be advised that conducting research activities without IRB approval is a violation of federal regulations. Furthermore, failure to provide a Site Status Report may lead to a finding of serious or continuing noncompliance which requires notification to the U.S. Food and Drug Administration.