Many clinical trials test treatments or drugs may potentially cause harm to participants. Even when using well known and common treatments, safety is still an important endpoint to consider for a trial. For example, combining two existing treatments or drugs together, or using a known drug in a different way may have different effects on people. Safety monitoring and reporting is absolutely required for all trials involving novel investigational medicinal products or investigational medical devices (referred to as therapeutic good trials) and for trials involving other types of intervention (referred to as non-therapeutic goods trials).
Robust systems are required to ensure all relevant side-effects (also known as adverse events; AE) are detected, recorded and the Sponsor of the trial notified in accordance with the protocol and any relevant policy and legislation.
To ensure adequate oversight of safety, Sponsors may also choose to have an independent committee to review safety data and monitor serious adverse events (SAE).
The Therapeutic Goods Administration (TGA) should be notified of any Serious and Unexpected Serious Adverse Events (SUSAR) that occur during a clinical trial.
If you wish to provide feedback or contact the team at the NSW Regional Health Partners Clinical Trials Roadmap please email ctroadmap@hmri.org.au
New South Wales Regional Health Partners respectfully acknowledge Aboriginal people as the past, present and future traditional custodians of the land and recognise their continued connection to land, waters and culture. We aim to partner with the Elders, community members and community controlled health services to improve health outcomes for Aboriginal people.