Documentation, Approval Needed to Justify Protocol Deviations

It’s not uncommon for a clinical trial site to have to make minor, unplanned changes to a study protocol, but failure to document and get such deviations properly approved can result in a warning letter. The FDA defines protocol deviations/violations as the “unplanned excursion from the protocol that is not implemented or intended as a systematic change,” according to its clinical investigator compliance program guidance manual. Any deviation from the protocol is a violation, even if it’s unintentional or a single occurrence, FDA spokeswoman Crystal Rice said.
Clinical Trials Advisor