Protocol Deviations

Unanticipated problems emerge when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reporting violations or deviations of a protocol are required to be made, in writing, to the IRB. (45 CFR 46.103(5)) Pursuant to federal regulations, the responsibility for reporting such noncompliance issues extends to principal investigators as well as any National Jewish Health faculty or staff that becomes aware of the noncompliance occurrence.

Protocol Deviation Form

Protocol Deviation Form Instructions

Protocol Deviations/Violations reporting Flowchart

Unanticipated Problems Policy