A protocol violation is an accidental or unintentional change to the IRB-approved protocol procedures without prior sponsor and IRB approval. Violations, as opposed to simply deviations, generally affect the subject’s rights, safety, welfare, and/or the integrity of the resultant data. Examples of protocol violations include (not an exhaustive list):
- Informed consent obtained after the initiation of study procedures
- Failure to obtain informed consent
- Failure to report a Serious Adverse Event