Protocol Outline Template

A protocol is a detailed plan of every aspect of the research study. It outlines the following information:

• Scientific basis for the project
• Study objectives
• Subject population(s)
• Methodology (study procedures)
• How data will be managed (data security plan)
• Evaluations and analysis plan
• Safety management and regulatory issues

The IRB provides a template protocol as guidance for what to include in a study protocol. The revised template includes prompts to provide specific information that will be requested in the HawkIRB New Project form.

Template Options

The Human Subjects Office Protocol Outline Template can be used for Phase I or non-clinical trials

Phase II-IV clinical trials should use the FDA/NIH Clinical Trial Protocol Template. There is also a Behavioral and Social Science Research protocol template on this page of the National Institutes of Health (NIH) website.

Separate Protocol Note Required

The IRB requires a separate, written protocol when the study is identified as a clinical trial.  The IRB reserves the right to request other physiology or clinical trial like research submit a protocol if the study is of a complex nature. The description of the study design and procedures in the HawkIRB application in those cases would not be sufficient. Applications for IRB-01 (biomedical) and IRB-03 (VA Health Care System) have a question (Section VII.B.11) asking whether there is a study protocol. If so, it must be attached to the HawkIRB application in the appropriate attachment category. If the project is a clinical trial, the IRB may request a separate, written protocol.

The IRB-02 (social/behavioral/educational research) application does not have Section VII.B, so there is no question about a separate, written protocol. However, researchers can still attach a protocol in the Miscellaneous attachment category.