3. Protocol non-compliance (self-reporting)

You should make a ‘non-compliance’ report as soon as possible upon awareness of a deviation / violation of your research protocol.

This is so that the ethics committee can review the appropriateness of such deviations, assess their impact and where necessary, work with you to keep subjects safe.

Non-compliance can happen for many reasons. It could be accidental, deliberate or unavoidable (such as to protect research subjects from impending hazards). It may affect one or many subjects. Examples of protocol non-compliance include: ^(15,16)

Recruitment of a subject who did not actually meet the inclusion criteria Having provided an older version of the participant information sheet to subjects Accidental unblinding of a subject’s intervention allocation Power failure affecting the storage conditions (e.g. temperature) of drugs Delay in the follow up of a subject * Loss of subjects’ data or biological samples

* Whilst it is important for your research protocol to be clear and specific, it does not need to be overly restrictive as this may lead to unnecessary non-compliance. For example, you may set a follow-up visit at 30 ± 5 days, instead of exactly 30 days. ⁽¹⁷⁾

^{Protocol non-compliance (2) →}