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:
|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)”.
A deviation is an instance(s) of failure to follow, intentionally or unintentionally, the requirements of the CIP.
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.