Develop Protocol

For investigator-initiated research, the Principal Investigator must draft a protocol outlining the intent, scope, and considerations for their trial. Templates are available from the Human Subjects Office, or can be obtained by contacting the Cancer Center’s Clinical Trials Office Protocol Development Team through the link provided below. The protocol should include research purpose, study aims, endpoints, target population, data collection methods, statistical considerations, and references. A Data and Safety Monitoring Plan may be needed based on trial risk; see Develop Data & Safety Monitoring Plan for details. Additionally, Principal Investigators must create study documents like informed consent forms and patient materials that need IRB approval before starting the study.

If the study is cancer related, study documents will first need to be approved by the Cancer Center’s Scientific Review Committee (SRC), prior to IRB submission.  For more information, please see Submit for Cancer Center Scientific Review.