The HDEC has provided guidance to NZACRes regarding reporting of protocol deviations/violations during the COVID-19 pandemic. Guidance on protocol deviation/violation reporting had previously been provided to DHB’s but not to the commercial sector. (HDEC meeting communication for DHBs 18-03-20
The HDEC is happy that during a National Level 3 and 4 COVID-19 response that protocol deviations for non-DHB/sponsored/commercial clinical trials are submitted monthly. However, if the deviation/violation is necessary to protect participants from an immediate hazard to their health and safety that is directly related to the study and is not due to COVID-19, then the HDEC must be informed within the time frames stipulated in the HDEC Standard Operating Procedures.
Where a protocol deviation/violations meets the definition of ‘substantial’ it must be reported to the HDEC. (Adapted from SOP for HDECs v3, Section 12, Clause 211.)
To determine whether a protocol deviation/violation is substantial, the same definition that is used for amendments applies.
SOP for HDECs v3, Section 11. Clauses 185 – 186
Definition of ‘substantial amendment’
185. A substantial amendment is an amendment that is likely to affect to a significant degree any of the following:
- the safety or physical or mental integrity of participants
- the scientific value of the study
- the conduct or management of the study
- the quality or safety of any medicine or item used in the study.
186. The following should normally be regarded as substantial amendments:
- significant changes to the design/methodology of the study
- significant changes to the type or number of procedures participants will undertake in the study
- changes relating to the safety of the physical or mental integrity of participants, or to the risk/benefit assessment for the study
- significant changes to the study’s documentation (such as participant information sheets)
- the appointment of a new CI for the study
- any other significant change to the study protocol or the information provided in the application for approval.