Preferred Label : Non-Institutional Review Board Independent Ethics Committee Approved Submission Document;
NCIt related terms : Submissions Non-IRB-IEC Committees; Subm Non-IRB-IEC;
NCIt definition : Records that describe the changes and/or updates made to a clinical trial, and are
submitted for approval to a committee other than the Institutional Review Board (IRB)/Independent
Ethics Committee (IEC).;
Alternative definition : CareLex: Study Site-specific documents that describe the clinical trial changes and/or
updates to the trial which are submitted to a committee other than the Institutional
Review Board (IRB) or Independent Ethics Committee (IEC) for approval. Such committees
include but are not limited to scientific, institutional, financial, data protection,
and/or biobank; includes non-IRB-IEC related submissions and correspondence. [Adapted
from TMF-RM];
Origin ID : C115716;
UMLS CUI : C3898128;
Semantic type(s)
- concept_is_in_subset
