Who should submit changes to Investigator Brochures, Package Inserts, or Device Manuals?

For centralized multi-site studies, Quorum Review IRB requests that sponsors submit the following documents on behalf of the investigators:

  • Investigator Brochures
  • Package Inserts
  • Device Manuals

When Investigator Brochures, Package Inserts, and Device Manuals are revised, Quorum Review IRB requires sponsors to submit a summary of changes along with the revised document to Quorum Review IRB on behalf of all investigators at the same time these revised documents are sent to investigators. In addition, it is especially helpful to provide a tracked version of the document showing the changes made.