Clinical monitor

The Clinical Monitor, also known as Clinical Research Associate (CRA) or Site Manager , monitors clinical trials (KP, defined in accordance with the Medicines Act § 4, Paragraph 23). This includes monitoring the implementation of the requirements of "Good Clinical Practice" ( Good Clinical Practice , short GCP), the Declaration of Helsinki and the relevant laws and regulations (u. A. Drugs Act , Medical Devices Act ) of the individual countries in which are performed the KP . Furthermore, he controls the implementation in accordance with the specifications of the study plan , the documentation of the relevant documentation sheets ( Case Report Form , CRF) and the use of the study medication. Since the clinical monitor is not a legally protected professional form and accordingly there is no statutory professional training in Germany, the clinical monitor must acquire scientific and medical knowledge itself.

The clinical monitor usually works in a pharmaceutical company , within a contract research institute , a coordination center for clinical studies (KKS) or independently , as a freelancer . In Germany there is now also the possibility of being qualified as a CRA at training institutes.

In Germany there is now also the possibility of completing a direct degree.

literature

• Reinhild Eberhardt and Charlotte Herrlinger: Monitoring and management of clinical studies: with ICH, AMG, MPG and EU guidelines. Editio Cantor; 5th edition 2010; ISBN 978-3-87193-389-9 .