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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:

  • Medical Device Regulation (MDR) 2017/745
  • Medical Device Directive (MDD; Richtlinie 93/42/EWG)
  • Medical Device Act (Medizinproduktegesetz; MPG)
  • MEDDEV 2.7/1 revision 4 (MEDical DEVices)
  • ISO 14155:2020
Suche nach Begriffen
Begriff Definition
end point - primary
A primary endpoint describes the principal indicator measured or determined to assess the primary objective of a clinical investigation.
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.
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.
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.