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Glossary

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
  • ICH-GCP
Search for glossary terms (regular expression allowed)
Term Main definition
patient
A patient describes an individual who participates in a clinical investigation, either as a recipient of the device under investigation or as a control.
Synonyms - subject
Paul-Ehrlich-Institute - PEI
The Paul-Ehrlich-Institute (PEI) is a competent authority and responsible for performance evaluations of high risk in vitro diagnostic agents.
project manager
A project manager is an individual or body with authority, accountability and responsibility for managing a project to achieve specific objectives.