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.