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.


Clinical Trial Protocol


Resource Plan and Budget

Further reading

  • Data Safety Monitoring Boards (DSMBs)
  • Risk-based Management and Monitoring of Clinical Trials involving Therapeutic Goods
  • Reporting of Serious Breaches of Good Clinical Practice (GCP) or the Protocol for Trials Involving Therapeutic Goods.