You have a plan for a clinical trial… but, so what? What will the result of the trial mean in the long-term? How will it change healthcare or patient outcomes? It is important to articulate the value of the trial to your patients, community and/or the health district (e.g. new treatment option, safer surgical procedures) through an impact statement.
The Australian Research Council defines research impact as the contribution that research makes to the economy, society, environment or culture, beyond the contribution to academic research.