Please note this CTRA FastPASS form is for a Clinical Trial Research Agreement (CTRA) where UNSW is the Sponsor for a project not considered a Clinical Trial. This includes studies where there is no intervention (Investigational Product: Medicine or Device).
What is a Clinical Trial?
At UNSW, Clinical Trials are defined as any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions (which may include placebo or other control) where the primary aim of the research is to evaluate the effect of the intervention on health outcomes.
If the project is a Clinical Trial please contact RECS - Research Ethics & Compliance Support (RECS) - Home
Requirements for this form:
- UNSW is the Sponsor
- There is no Investigational Product (medicine or device)
- Contract is required for a Study Site – location where the Study will be conducted
GENERAL TERMS
Medicine’s Australia CRG CTRA – 8 March 2017 (revised)
You can download and share a copy of the agreement with the Study Site and submit a FastPASS form below
