Operations Manual — The University of Michigan Human Research Protection Program Operations Manual (OM) is designed to illuminate the University of Michigan's overarching governing rules and to serve as a reference for investigators, IRBs, administrators, and other members of the research community.
Standard Operating Procedures — The Institutional Review Boards of the University of Michigan Medical School Standard Operating Procedures (SOPs) serve as the overarching guidelines for IRBMED practices and procedures.
Glossary — The IRBMED Glossary is a compilation of regulations, terms, and acronyms related to human subjects research. The contents of this glossary have been collected from a variety of authoritative sources.
Simplification Guide to Medical Terms — The Simplification Guide can be used to explain medical concepts in terms that non-specialized readers are more likely to understand.
Electronic Records and Electronic Signatures (21 CFR Part 11) — Part 11 provides criteria under which FDA will consider electronic records to be equivalent to paper records and electronic signatures to be equivalent to traditional handwritten signatures.
To find guidance on a particular topic, you may either click on one of the following letters or scroll down through the alphabetical listing.