COVID-19 Research Resources
A curated list of research resources around guidelines, policies, and procedures related to COVID-19, drawn from Harvard University, affiliated academic healthcare centers, and government funding agencies

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

Quality Assurance/Quality Improvement (QA/QI)

Overview

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.

Resources

For Investigators and Institutions
  • Harvard Catalyst QA/QI Consulting Service
  • 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.
  • 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)
  • Human Subject Research Determination Checklist [PDF]
    A checklist used to conduct a quality improvement assessment of determinations for human subject research.
  • IRB Meeting Minutes Checklist [PDF]
  • Expedited Review Checklist [PDF]
  • 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.
  • QA/QI Poster at PRIM&R Conference 2015 [PDF]
  • 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 Quality Assurance/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.

Harvard Catalyst Collaborative Quality Improvement Program (CQIP):

The Collaborative Quality Improvement Program (CQIP) is a part of the Harvard Catalyst Regulatory Program which meets to help small institutions or human research protection programs (HRPP) develop their quality assurance and improvement (QA/QI) activities.

Contact

For more information, please email us.