Guidance on protocol deviation submissions

While minor protocol deviations are to be submitted with the annual progress report, the following protocol deviations should always be regarded as important and submitted in a timely manner using the ERM Protocol Deviation Form:

1. Enrolment of a participant in violation of study eligibility criteria.
2. A participant undergoing study assessments not included in the study information sheet the participant had consented to. For multi-part studies, this includes a participant undergoing assessments for, or being enrolled into, a part of the study for which specific consent had not been provided.
3. Privacy breach.
4. Use of tissue for purposes that the participant had not consented to. This includes collection of samples for optional study components not consented for by the participant.
5. Dosing errors, including administration of investigational product to the wrong participant, administration of the incorrect dose, or failure to adjust dose / dose rate where required per protocol.
6. Commencement of the study at a site in the absence of a required locality authorisation.
7. Pregnancy in a participant or participant’s partner, in a study where pregnancy is to be avoided.
8. Use of unapproved advertising material.
9. For-Cause audit reports and findings, and other site or study audits by a regulatory agency such as the FDA where serious or significant adverse findings are reported. In all cases, a Corrective Action Plan should also be submitted for review.
10. Any other protocol deviation that is deemed significant by the Coordinating Investigator or study Sponsor, or that places the affected participant(s) at increased risk of harm.

Further information

Submission of Protocol Deviations is outlined in the Standard Operating Procedures for Health and Disability Ethics Committees (para 210-214)

For help in determining whether something requires submission as a protocol deviation, contact the HDECs Secretariat:

• email: hdecs@health.govt.nz