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.