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.