There is no official definition of a protocol deviation or violation, but the following may serve as a guide:
A protocol violation is a failure to comply with the study
protocol as approved by the Ethics Committee. A violation is a
serious non-compliance with the protocol that can result in the
exclusion of a patient or their results in the study and in some
cases a charge of research misconduct;
A protocol deviation is a less serious non-compliance with the approved study protocol.
A protocol deviation presented in advance of the event may be considered acceptable by the sponsor (if any)
and the Ethics Committee.
Reporting Protocol Deviations/Violations to the Ethics Committee
Researchers should provide written details to the Ethics Committee
of protocol violations or deviations when:
- There are safety or ethical implications for the participant(s)
- The scientific integrity of the study is affected (normally the sponsor
will advise this)
- The protocol methodology causes the protocol deviation/violation
to occur (eg. exclusion criteria too strict)
- The conduct of the study causes the protocol deviation/violation
to occur (eg. rotating staff not detailing consent procedures in patient notes).
Researchers should provide the following details to the Ethics Committee using the
Protocol Deviations/Violations Form:
- Project number and name
- Name and signature of the principal researcher
- Details of the deviation/violation
- The impact of the deviation/violation on patient safety and/or scientific integrity
- Evidence of acceptance of the deviation by the sponsor, if relevant
- What steps have/are to be taken to avoid a recurrence
Please email the completed form to
acknowledgement receipt will be sent by return email.
- If any changes to the project/protocol are required, an
amendment should be submitted to the Ethics Committee.
- The Ethics Committee is under no obligation to approve a protocol deviation presented in advance.