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:
|blinding / masking||
Procedure in which one or more parties to the clinical investigation are kept unaware of the treatment assignment(s).
Single blinding usually refers to the subject(s) being unaware of the treatment assignment(s).
Double blinding usually refers to the subject(s), investigator(s), monitor and, in some cases, centralized assessors being unaware of the treatment assignment(s).
|Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM||
The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) is as an competent authority responsible for clinical investigations of medical devices and for performance evaluations of in vitro diagnostic agents, with the exception of those for which the Paul-Ehrlich-Institute is responsible.