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..

Apr 7 • Clinical trail, CRA certification, cracertification_Q&A, cracertification.co.uk • 4714 Views • No Comments on 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..

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..

Answer:

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.

Thanks for installing the Bottom of every post plugin by Corey Salzano. Contact me if you need custom WordPress plugins or website design.

Related Posts

This site uses Akismet to reduce spam. Learn how your comment data is processed.

« »

%d bloggers like this: