Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program
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Quality Assurance/Quality Improvement (QA/QI)


Drawing from expertise throughout Harvard Catalyst's participating institutions, the Regulatory Foundations, Ethics, and Law Program facilitates the development and strengthening of QA/QI programs by educating the research community, enabling compliance, and collaborating around issues relating to regulatory compliance.

Quality Assurance/Quality Improvement (QA/QI) functions ensure investigator and institutional compliance with federal and state regulations governing human research. This is accomplished by providing ongoing support, education and study management tools, and best practice recommendations that go above and beyond mere compliance, with an emphasis on improving efficiency.


For Investigators
  • Regulatory Binder
    A customizable documentation system for tracking, maintaining, and achieving regulatory compliance, catering to either biomedical or social-behavioral research.
For Institutions
  • QA/QI 101 [PDF] (coming soon)
    An introduction to QA/QI programs, including responsibilities, scope of authority, and development of a successful program.
  • QA/QI Handbook (coming soon)
    Tools for designing, developing, staffing, and running an effective QA/QI program.
  • Request a Consult
    The QA/QI Consulting Service offers consultation to help institutions and IRBs develop and improve QA/QI resources and/or necessary expertise. The consulting service aims to increase research compliance by providing education and training for investigators, study teams, IRB members, and other members of the research community.
  • Model Audit/Review Tools (Request Audit Tools)
    A comprehensive template for performing audits. Includes sections to enter general information, investigator interview, research personnel, record keeping, genetic research, participant form, participant files, and participant eligibility.
  • Audit Standard Operating Procedure - Request SOP
    The SOP for conducting audits for multi-institutional studies where IRB review has been ceded under the Harvard Catalyst Reciprocal Common IRB Reliance Agreement.
  • Preparing for an FDA IRB Inspection (FDA)
    Information about preparing for an FDA Institutional Review Board inspection, including: what to expect on inspection day, pre- and post-inspection processes, common deficiencies, and points to consider.
  • Harvard Catalyst Continuous Quality Improvement Subcommittee (QA/QI):

    The Harvard Catalyst QA/QI Subcommittee includes recognized QA/QI leaders and IRB members from participating Harvard Catalyst institutions. The Subcommittee also engages those new to the regulatory compliance arena who offer fresh perspectives and novel approaches to a problem. Each member brings a range of experience and familiarity: from social behavioral to biomedical research, from single-site, local research to multi-center, international studies. Learn more on our How We Work page.

  • Connect with a QA/QI expert via the Harvard Catalyst Regulatory Atlas.


Leslie Howes
QA/QI Co-Chair

Sarah White
QA/QI Co-Chair

Sabune Winkler, JD
Director, Regulatory Affairs Operations

Hila Bernstein
Regulatory Affairs Officer