Question5. Please, try to list the main functions of Clinical Research Associate in the interaction between FDA/TPD, Sponsor, CRO, IRB, and the Investigator. In the next sessions we will talk about these functions..
Clinical Research Associate (CRA) is a professional who monitors the administration and progress of a clinical trial (pharmaceuticals, biologics, or devices) on behalf of a sponsor. A clinical trial is a scientific study of the effects, risks and benefits of a medicinal product, including new drug substances and currently marketed drugs. A CRA might also be called a clinical research (or trials) monitor, executive, scientist or coordinator, depending on the company.
Typical work activities include:
locating and briefing suitable doctors/consultants (or investigators) to conduct the trial; setting up the study centers – ensuring each center has the trial materials and checking that the investigator knows exactly what has to be done; monitoring the trial throughout its duration which involves visiting the study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise; validating and collecting completed CRFs from hospitals and general practices; closing down study centers on completion of the trial; discussing results with the statistician. Writing technical reports on the trial is usually carried out by a medical statistician.