Minimal Risk Protocol

A Minimal Risk Interventional or Observational study is one that includes a minimal risk procedure that is generally not included within standard of care for this patient population (e.g., exhaled breath sample, ultrasound, etc).

1. Create a written protocol using the Minimal Risk Interventional Protocol Template. Below are some examples of a minimal risk 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. Create a Data Collection Form. Below are some examples:
• First example
• Second example
• Third example


5. Email all of the above to CRP. You will be contacted shortly with further instructions (including the level of subject consent required) and the correct IRB application to complete.

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

Contact CRP for additional assistance with protocol development, statistical resources, funding questions, etc.