Clinical trials decision tool Step 1 of 2 Does the project involve human participants? Yes No Are participants prospectively assigned to an intervention The term prospectively refers to a pre-defined process that assigns research participants to one or more arms. Yes No Is the project designed to evaluate the effectiveness of the intervention on the participants? Yes No Is the effect that will be evaluated a health-related biomedical or behavioural outcome? A health-related biomedical or behavioural outcome is a pre-defined goal or condition reflecting the impact of interventions on participants' biomedical or behavioural status or quality of life. Yes No Your project is not classified as a clinical trial. Your project is classified as a clinical trial.Please continue to find out whether you also need to notify the Therapeutic Goods Administration (TGA) of your clinical trial. Is the aim of the research to evaluate the effect of a health-related intervention for the development of a health-related treatment within Australia? Yes No Your clinical trial may require notification to the TGA.Please notify the TGA of the clinical trial via their Clinical Trial Notification/Clinical Trial approval process, at https://www.tga.gov.au/clinical-trials.
