Skip to main content
eScholarship
Open Access Publications from the University of California

Education and Guidance Documents

About Education and Guidance Documents: TODO
Cover page of Quality Improvement (QI) <em>Project</em> vs Quality Improvement (QI) <em>Research</em>

Quality Improvement (QI) Project vs Quality Improvement (QI) Research

(2019)

Regulatory guidance for determining QI Project Activities from QI Research Activities

Cover page of Post-Approval Investigator Responsibilities (PAIR) Worksheet

Post-Approval Investigator Responsibilities (PAIR) Worksheet

(2019)

Worksheet and guidance to help researchers with their post-approval regulatory responsibilities and tools to ensure project management success

Cover page of Protocol <em>Regulatory and Internal Congruence Worksheet</em>

Protocol Regulatory and Internal Congruence Worksheet

(2019)

A worksheet to help ensure internal congruence within a research protocol.

Cover page of The Revised Federal Policy for the Protection of Human Subjects - A Summary, and an Implementation Roadmap and Matrix

The Revised Federal Policy for the Protection of Human Subjects - A Summary, and an Implementation Roadmap and Matrix

(2018)

On January 19, 2017, the U.S. Department of Health and Human Services (HHS) and fifteen other Federal Departments and Agencies announced revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was originally promulgated as a Common Rule in 1991. The Final Rule will be effective January 21, 2019, with the exception of cooperative research (single IRB review) which will not be effective until January 20, 2020. The key revised elements of the federal policy are outlined in the table below.

  • 3 supplemental PDFs
Cover page of Stepwise Method to Determine Medical Device Research Regulatory Status

Stepwise Method to Determine Medical Device Research Regulatory Status

(2018)

A checklist to determine the research regulatory status of medical devices.