Yes. Quorum has a form called the Observational Registry or Qualified Minimal Risk Site Status Report used for periodic site review or closure. This form is available on Quorum’s website. Quorum will also send a copy of the Observational Registry and Qualified Minimal Risk Site Status Report prior to the site’s anniversary.

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.

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.

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.

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.