The following protocol templates are available to assist you in developing a standalone protocol:
- For biomedical clinical investigations evaluating drugs and/or devices, the following templates include guidance specific to the FDA requirements:
- For biomedical studies NOT evaluating a drug and/or device, we recommend using the IRB Toolkit template, HRP-502-TEMPLATE PROTOCOL -Biomedical
- For registry and/or repository studies, see HRP-503a-PROTOCOL TEMPLATE-Registries and Repositories
- While these studies are likely to be minimal risk, they must include specific kinds of information to enable the IRB to make the relevant regulatory determinations. The IRB Toolkit’s registry and repository protocol template is the most efficient way for you to provide the information the IRB needs.
You may use other templates to develop a protocol. When reviewing protocol documents, the IRB uses HRP-503-TEMPLATE PROTOCOL as a reference point for basic content that should be included. Including this basic content in your document (plus additional information if appropriate for your study) will help ensure the IRB has the information it will need for review.