The glossary explains some important terms used in clinical research and clinical trials. In addition to our own knowledge and expertise, the following sources were used to define the terms:
| Begriff | Definition |
|---|---|
| conformity assessment |
Conformity assessment means the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.
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| contract research organization - CRO |
A person or organization contracted by the sponsor to perform one or more of the sponsor's clinical investigation-related duties and functions.
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| coordinating (clinical) investigator |
Clinical investigator who is appointed by the sponsor to coordinate work in a multicentre clinical investigation.
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| corrective action |
Corrective action means action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
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| corrective and preventive action - CAPA |
Corrective and preventive action (CAPA) is a process which investigates and solves problems, identifies causes, takes corrective action and prevents recurrence of the root causes.
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| custom-made device |
A custom-made device is a medical device which is especially manufactured according to a written prescription and with specific design features and intended for the exclusive use of a patient designated by name. Mass-produced medical devices which need to be adapted to suit the specific requirements of the physician, dentist or other professional user, are not regarded as custom-made medical devices.
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