Does Quorum issue approval for Investigator Brochures (IB) and other product information?

Quorum requires submission of an IB for the initial review of every IND protocol. The IB is important to the review of a protocol, in that it provides information that is necessary to assess the overall risks and benefits of the research; however, Quorum Review does not “approve” or “disapprove” this document.

Should the IB be updated during the course of a study, acknowledgement of the revised document is provided to the sponsor and all active sites, if requested by the sponsor, in order to document that Quorum Review has been adequately notified of additional safety information provided since the initial review.