A research protocol forms the document that outlines the study plan and the basis for how a study is run. A well written and complete protocol is essential for a high quality study, for safeguarding the health and safety of participants and answering a specific research question. Time spent on writing a detailed protocol will avoid problems during the study, and will make publishing the results easier. A complete protocol is also essential for the study to be approved by an ethics committee and to be compliant with NHMRC regulations. Protocols are also required for funding applications.

1. Writing your protocol

To ensure that your protocol is complete, layouts and templates are available to guide you. For example,

The Food and Drug Administration (FDA), National Institute of Health (NIH), National Health and Medical Research Council (NHMRC) and the Therapeutic Goods Association (TGA) all have information on their websites to assist with protocol development (See Links section)

2. Register your trial on a Public Trials Registry

All randomised trials need to be registered on a public trials register. Health-related interventions include any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes). Health outcomes include any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. Many journals will not publish results from studies which have not been registered with an acceptable Public Trials Register. Examples of acceptable registers are: