Interventional Protocol

A Interventional Protocol is a study in which participants are assigned to groups that receive one or more interventions or treatments..

1. Create a written protocol using either of the two following Interventional Protocol Templates:
   • ITHS Protocol Template or
   • Common Protocol Template.

   Below are some examples of an interventional protocol:

   • First example
   • Second example
   • Third example
   
   
2. Complete the New Study Form.


3. Gather or create any questionnaires/surveys to be utilized in the study.


4. Complete the Consent using the template and checklist. Assistance from the IRB staff is available upon request at IRB@BenaroyaResearch.org.


5. Create a Data Collection Form. Below are some examples:
• First example
• Second example
• Third example


6. Email all of the above to CRP. You will be contacted shortly with further instructions.

You May NOT Begin Your Research Project Prior To CRP And IRB Approval.

If necessary, register your study at ClinicalTrials.gov. Here is a checklist and some guidance for which trials must be registered. Please contact CRP for additional assistance with protocol development, statistical resources, funding questions, etc.