When something unusual or unexpected occurs, you should create a “note to file” to explain the situation (who, what, where, when, why, how) and the appropriate corrective actions, including resolving the current situation and preventing future occurrences. Examples could include obtaining pencil signatures rather than pen, failing to obtain subject initials, etc.
Protocol deviations that should also be reported to the IRB include deviations that:
- Affect subject rights/welfare
- Affect subject safety
- Affects integrity of the study data
- Could affect the subject's willingness to continue study participation
- Any deviation specifically required by the sponsor, institution, or the IRB