Understanding if your study is a clinical trial is an important first step. The World Health Organisation defines a clinical trial as ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’. These may include patient, family, care-provider or community level interventions. Clinical trials may test new or existing interventions or observe how people respond to other factors that may affect their health.

Clinical trial interventions include but are not limited to:

• Surgical procedures
• Medical treatments and procedures
• Psychological, behavioural treatments and social interventions
• Experimental drugs and medicines
• Diagnostic tests
• Medical devices
• Health-related service changes, preventative strategies or educational interventions.

You can use this decision tree to decide if your study is a clinical trial.
Reference: NIH Central Resource for Grants and Funding Information, Clinical Trials Decision Tree