Research and Regulatory Tools & Resources

Study Documentation Templates and Regulatory Binder tabs: Templates that will help you manage regulatory documentation for your research study.

Self-Assessment Review Tools: Easy-to-use checklists can help you assess your study documentation and conduct in multiple areas: consenting documentation and process, inclusion/exclusion criteria, and protocol adherence.

Regulatory and Ethics Links and Guidance: Ever have trouble finding the guidance document you need? Here is a simple to use list!

Informational Brochures for Research Subjects or Prospective Subjects: The Boston University Clinical and Translational Science Institute (BU CTSI) participates in the New England Research Subject Advocacy (NE RSA) Consortium (including BU, Harvard, Tufts, Yale, and Dartmouth CTSIs) to support the research community and participants. One of the initiatives has been the development of informational brochures to help researchers communicate and discuss, in plain language, various aspects of research. These brochures are available for download in multiple languages on the Harvard Catalyst website. Scroll to “Brochures.”