2. Complete the Study Protocol: An IDE Requires a Fully Developed Protocol

A fully developed protocol is the basis for both the IRB Application and the initial IDE submission:

  1. For assistance in developing your protocol, Contact the School of Medicine Clinical Trials Office or if you are affiliated with the Cancer Center, contact the Office of Clinical Research.  A completed protocol must be included in the IDE application.
  2. We suggest you start full protocol development by developing a protocol synopsis.  The protocol synopsis will detail the study objectives, primary and secondary endpoints, inclusion/exclusion criteria, patient enrollment goals, basic study procedures and statistical plan in addition to a Time and Events table.    If you are planning a pre-IDE meeting, the protocol synopsis is sufficient.
  3. Compile a reference list – include all published articles and unpublished reports or manuscripts cited.  Collect a copy of each article or report listed.