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:
HRP-503- Template Protocol (To optimize use of this template, enable macros by choosing “enable content” when you open the document).
NIH and FDA Clinical e-Protocol Writing Tool – This is an electronic protocol building tool 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). Form 7 will serve as the protocol for these studies.
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).
Subject Wallet Card
This subject wallet contact information card has been approved by the Tufts Health Sciences IRB for use.
Please consider providing this wallet card to subjects so they can easily access study contact information.This card has been approved by the Tufts Health Sciences IRB and can be used in a specific study without further IRB approval, provided the information on the card is restricted to the information in the template (contact name, phone #(s), address/location, e-mail address, and appointment reminder). The size of the card and the font type can be altered without further IRB approval. If you would like to include additional information or make further alterations on the card (beyond the allowed alternations described here), please submit it to the IRB for review and approval prior to use.