The chief investigator of a clinical trial is responsible for the design, conduct and reporting of the trial. This includes ensuring the welfare of participants whilst in the trial, the safety of staff and that the trial is conducted according to good clinical practice and legal requirements.
For each study a risk assessment should be undertaken at the protocol development stage. This may be used to plan the details of study management and the approach to, and extent of, monitoring in the study. These plans should be documented, together with the risk assessment, so that the management strategy is both transparent and justified. This risk assessment is intended not only to facilitate the management of the study but also to help prepare for external audit.
All clinical trials need to undergo a risk assessment before the study is ‘opened’ so that foreseeable risks and inconveniences can be weighed against the anticipated benefit for individual trial subjects and the general population as a whole.
A trial must only be initiated and continued if the anticipated benefits justify the risks.