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*NEW protocol template document below.  Call the IRB office at 617-636-7512 if you have any questions.

Every prospective human subjects 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 a 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 IRB office has provided the following protocol templates:

(To optimize use of this template, enable macros by choosing “enable content” when you open the document).

SOPs referenced in Template Protocol

SOP: Legally Authorized Representatives, Children, and Guardians (HRP-013)

SOP: Informed Consent Process for Research (HRP-090)

– SOP: Written Documentation of Consent (HRP-091)

  • Clinical Trial Protocol Template – This draft protocol template was created by the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA) for phase 2 and 3 IND/IDE studies.
  • Form 7 (Record/Database/Specimen Review) – Required for retrospective medical record/chart/electronic database/specimen review and databases created for research purposes. When submitting a Form 7, there is no need to submit a separate protocol (and no need to submit a Form 1). For 7 will serve as the protocol for these studies.

Other Resources

This website provides recommendation of scientific, ethical, and administrative elements that should be addressed in a clinical trial protocol.  Included are a useful checklist (WORD | PDF) and example table of assessments (WORD | PDF).