Research Ethics, Governance & Integrity (REGI) Unit

In November 2016, the NHMRC revised its guideline for Safety Monitoring and Reporting of research.

The recently released document, ‘Safety Monitoring and reporting in clinical trials involving therapeutic goods’ is designed to clarify the responsibilities of all parties in relation to safety monitoring and reporting  of all adverse events occurring in clinical trials. 

In summary, the key change in the revised guideline places the responsibility for safety monitoring and reporting requirements with the sponsor of a clinical trial, defined as ‘an individual, organisation or group taking on responsibility for securing the arrangements to initiate, manage and finance a study’.  A sponsor should be identified for all clinical trials and all sponsor functions, including safety monitoring and reporting should be clearly allocated or delegated. The guideline advises that, to ensure appropriate independent oversight of safety within a clinical trial, sponsors should utilise an independent committee or independent individuals (e.g. Data Safety Monitoring Boards, or  a medical monitor) to review accruing safety data. The outcome of these reviews should be provided to the HRECs, investigators, institutions and the Therapeutic Goods Administration (TGA).

To reflect the updated NHMRC guideline  Barwon Health has also revised its advice to researchers  and provides the following summary to  clarify the role  of all research stakeholders in addressing the monitoring, collection and reporting of adverse events that occur in clinical trials involving investigational medicinal products (IMPs) and investigational medical devices (IMDs).