Protocol Template Document

Every human subject research study must have a protocol. When a study is sponsored by industry, a protocol is typically provided by the sponsor. If a protocol is not provided by the sponsor, or a study is initiated by the Principal Investigator (PI), the PI must create the detailed protocol for the study. If a protocol does not accompany the submission to the IRB it will delay the review of the research.

To assist with the creation of a protocol, the institutions have created a guidance document and a template for researchers. When creating a protocol, please refer to the guidance document detailing protocol requirements to ensure that all of the required information is present. An incomplete protocol will result in delays and will be returned to the PI. A protocol template that a researcher may complete is also available; again, please refer to the guidance document detailing protocol requirements to ensure that all of the required information is included.

• Guidance document detailing protocol requirements
• Blank protocol template for researchers