Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

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.
  • Electronic Regulatory Binder Project
    The eReg Binder is a REDCap project developed by the Partners Human Research Quality Improvement (QI) Program and Enterprise Research Infrastructure & Services (ERIS). The eReg Binder assists sites with the electronic storage and maintenance of regulatory documents for IRB-approved protocols. The eReg Binder is available through the REDCap consortium.
    • If you are interested in using the binder, please contact the REDCap Administrator at your institution to find out if the template is available for use.
    • If you are a REDCap Administrator interested in adding the template to your environment, full instructions are available. For additional information, please contact EDC Support.
  • Investigator Self-Assessment Checklists [PDF]
    A comprehensive series of checklists designed for either investigators, their study staff, or QA/QI programs to implement in order to evaluate investigator compliance. (Request a Word version)
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.
  • Investigator Self-Assessment Checklists [PDF]
    A comprehensive series of checklists designed for either investigators, their study staff, or QA/QI programs to implement in order to evaluate investigator compliance. (Request a Word version)
  • 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.


Eunice Newbert, MPH
QA/QI Co-Chair

Sarah White, MPH, CIP, RAC
QA/QI Co-Chair

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations

Jacquelyn-My Do
Regulatory Affairs Officer