IRB Protocol Development Assistance

These collected resources can help when you're developing IRB protocols and related materials. If you have further questions after reviewing these materials, please contact our office. We also encourage students and residents to work with their advisors during this process.  

  1. The principal investigator (PI) should write the protocol because he or she understands the project and its purpose. 
  2. Start with the protocol because other documents build on that information.
  3. Other documents to create early in the process include the data collection instruments.
  4. If you're new to this IRB process, ask someone to review your protocol before proceding to the other documents.

 

BRO/CRO Recomended Guidance Materials

Selected IRB Toolkit Items

You can find the complete toolkit within the Click IRB system or on the IRB Toolkit page. The following are some of the most commonly used items.