Clinical research associate

Author: Prof. Dr. med. Peter Altmeyer

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Last updated on: 29.10.2020

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Synonym(s)

Clinical monitor; CRA

Definition
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A Clinical Research Associate (CRA) is a medically qualified employee of the sponsor or the Clinical Research Organisation (CRO) in clinical trials. The task of the monitor is to check and ensure data quality and regulations including the Declaration of Helsinki, the implementation of Good Clinical Practice (GCP) and compliance with the protocol.

General information
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A Clinical Research Organisation (Contract Research Organisation - CRO) takes over the planning and execution of clinical studies. These can be approval studies or non-interventional studies from the field of drug studies (AMG) or medical device studies (MPG).

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Last updated on: 29.10.2020