Quality assurance (clinical trials)

Definition:

Measures taken to ensure that a clinical study is conducted and reported according to its agreed protocol, and in accordance with Good Clinical Practice and any other relevant regulatory requirements.

Quality assurance is based on a planned and systematic set of activities to ensure that all aspects of a clinical trial are carried out to a high standard. These activities are essential to protect the health and wellbeing of participants in trials and to ensure that the data obtained are reliable.