Clinical trials

NCAT must approve all clinical trials which seek to involve a person aged 16 years or older with a decision making disability.

Clinical trial applications are managed through NCAT's Guardianship Division.

Why is approval of a clinical trial required?

A clinical trial conducted in NSW, which may include persons who are 16 years of age or older who are unable to provide informed consent to treatment, must have the approval of the Tribunal under Part 5 of the Guardianship Act 1987​.

A clinical trial is a trial of a drug or intervention technique that involves giving medical treatment to the trial participant. Trials may relate to a new drug or the use of an existing drug in a way or for a purpose that has not yet been approved.

NCAT can only approve a clinical trial if it is satisfied that the trial meets certain criteria. Refer to the Clinical trials fact sheet (PDF , 132.9 KB) for further information.

How to apply to NCAT

Applications for the approval of a clinical trial can only be made by a representative of the pharmaceutical company proposing the trial or by the principal investigator of a centre proposing to conduct the trial.

Complete the clinical trials application form and lodge with NCAT's Guardianship Division.  There is no fee for lodging a clinical trial application.

Fact sheets

A wide range of helpful fact sheets about applications dealt with by NCAT's Guardianship Division are available on the Guardianship Division fact sheets page.

Return to top of page Back to top