What materials do I need to submit prior to the chairperson study assessment?

Please submit a draft or final version of your protocol and any supplementary materials such as investigator’s brochures, package inserts, or device background literature for all primary and comparator drugs/devices. In addition, if there are specific questions regarding the informed consent document, it may be helpful to provide a copy of the proposed informed consent. It is also helpful to provide a list of questions for discussion ahead of time to help guide the discussion.