Preferred Label : Clinical Trial Independent Data Monitoring Committee Charter;
NCIt related terms : Data Monitoring Committee; Data Safety Monitoring Board (DSMB) Charter; Independent Data Monitoring Committee Charter; DataMonitoringCommitteeCharterVersion; IDMC Chart; IDMC Charter; DSMB Charter;
NCIt definition : Records describing the purpose and operation of the Independent Data Monitoring Committee
(IDMC).;
Alternative definition : CareLex: A document describing the purpose and operation of the Independent Data Monitoring
Committee (IDMC), which may be established by the sponsor to assess the progress of
a clinical trial at intervals, the safety data and the critical efficacy endpoints,
and to recommend to the sponsor whether to continue, modify or stop a trial. [Adapted
from TMF-RM]; BRIDG 5.3: A key document that, together with the study protocol and Statistical Analysis
Plan (SAP), prospectively defines the study's Data Monitoring Committee (DMC) infrastructure
and, in particular, the DMC's responsibilities; stipulates who sees blinded results
and who sees unblinded results; and establishes a method for communication between
the DMC and the sponsor. EXAMPLE(S): OTHER NAME(S): NOTE(S):;
Origin ID : C115650;
UMLS CUI : C3890568;
Automatic exact mappings (from CISMeF team)
- Semantic type(s)
- concept_is_in_subset
