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 |
|---|---|
| data monitoring committee - DMC | Independent committee that may be established by the sponsor to assess, at intervals, the progress of the clinical investigation, the safety data or the critical performance endpoints and to recommend the sponsor whether to continue, suspend, modify, or stop the clinical investigation. Examples of DMCs are “data safety monitoring board (DSMB)” or “data safety monitoring committee (DSMC)”. |
| deviation |
A deviation is an instance(s) of failure to follow, intentionally or unintentionally, the requirements of the CIP.
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| device deficiency |
A device deficiency is described by an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
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| end point - primary |
A primary endpoint describes the principal indicator measured or determined to assess the primary objective of a clinical investigation.
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| end point - secondary |
A secondary enpoint describes the indicator measured or determined in addition to the primary end-point to assess some other objective of a clinical investigation.
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| ethics committee |
The ethics committee is described by an independent and properly constituted competent body whose responsibility is to ensure that the safety, wellbeing and human rights of the subjects participating in a clinical investigation are protected.
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| exclusion criteria | An exclusion criteria is a characteristics of an individual which disqualify them from taking part in a clinical investigation. See also inclusion criteria. |
| Federal Institute for Drugs and Medical Devices | |
| field safety corrective action |
A field safety corrective action means a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
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| field safety notice |
A field safety notice means a communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
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| incident |
An incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market.
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| inclusion criteria | An inclusion criteria is a characteristics of an individual which qualify them from taking part in a clinical investigation. See also exclusion criteria. |
| informed consent |
Informed consent means a subject's free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject's decision to participate.
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| instruction for use - IFU |
The instruction for use provides information about the medical device like the intended purpose, the proper use and any precautions to be taken. It addresses the user of the medical device and is provided by the manufacturer.
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| intended purpose |
The intended purpose describes the use for which a device is intended according to the data supplied by the manufacturer on the label and in the instructions.
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