Why don’t our sites have stamped approved copies of the Diaries and Questionnaires (protocol study tools) submitted with the initial protocol?

Prior to March 1, 2010, protocol study tools were considered part of the protocol, and Quorum processed them as we would the protocol or any amendments to the protocol. We issued approval for the material on Notice of Approval documents for protocol study tools that were reviewed with the initial protocol submission and we issued approval on Amended Approval documents for protocol study tools that were approved during the course of a study. We did not distribute Quorum Review-approved stamped copies of protocol study tools to sites as we did not issue Quorum Review-approval stamped copies of the protocol to sites.

Protocol study tools submitted after March 1, 2010, will be processed as participant study materials and a “Quorum Approved” stamped copy of the protocol study tool will be provided with the approval document.