The Clinical Research Associate (CRA), often known as the Study Monitor, is appointed by the Sponsor or CRO to supervise the conduct of the study in the Investigator's study centre.
The Clinical Research Associate is responsible for maintaining and supervising a full audit trail of telephone calls, letters and any other contact; for reporting to the Sponsor on the progress of the trial and for verification of data.
The Clinical Research Associate must have appropriate
qualifications and experience to enable a knowledgeable supervision
of the particular trial. Trained technical assistants may help the
CRA to collect and process data.