Clinical Research Protocol Checklist

Download Protocol Checklist_10.25.2019

A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research study. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol. The tool below includes both the ICH GCP recommendations for protocol content with some additional considerations provided by the UW-Madison Health Sciences IRB. Additional information may be provided on separate protocol page(s), or addressed in a separate agreement, and some of the information listed below may be contained in other protocol referenced documents, such as an Investigator’s Brochure.

Updated 11/21/2019