A draft FDA guidance on protocol deviations has been posted for comment. This guidance contains, among other tidbits, proposed definitions for “important protocol deviation” and “protocol deviation.” The guidance touches on considerations that might minimize protocol deviation occurrence, such as careful protocol design that allows appropriate flexibility, and offers information about reporting and reviewing deviations.
While the draft guidance is specific to FDA-regulated research, the information it provides nicely complements OHRP regulations and UAMS IRB policies regarding protocol deviations.
This draft guidance is open for comment until February 28, 2025.