Regulatory guidance for determining QI Project Activities from QI Research Activities
Worksheet and guidance to help researchers with their post-approval regulatory responsibilities and tools to ensure project management success
A worksheet to help ensure internal congruence within a research protocol.
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.
A checklist to determine the research regulatory status of medical devices.