A protocol violation or non-compliance is any deviation from the protocol, study or sponsor procedures that is not approved by the sponsor/REC/MHRA prior to its implementation.
A minor violation/ non-compliance is one that does not impact the subject’s safety or compromise the integrity of the study data. However, if left unreported could lead to more major violations/non-compliance issues further down the line. An example of a minor violation would be:
- Missing an original signed consent form.
A major violation/non-compliance is one that may impact the participant's safety or affects the integrity of the study data. An example of a major violation would be:
- Failure to obtain informed consent
- No evidence of medical assessment of eligibility being enrolled into a CTIMP
A minor or major protocol violation should be reported to the sponsor within 24 hours of becoming aware of the violation by the Chief Investigator or Principal Investigator.