Preferred Label : Institutional Review Board Independent Ethics Committee Submission Documentation;
NCIt related terms : IRB-IEC Submission; IRB/IEC Submission; IRB-IEC Subm; Institutional Review Board Independent Ethics Committee Submission; IRB or IEC Submission;
NCIt definition : Documentation submitted to an Institutional Review Board (IRB) or Independent Ethics
Committee (IEC) for approval of the details of a clinical trial, and any changes or
updates made to that trial.;
Alternative definition : CareLex: Study Site specific document describing the trial, changes or updates to
the trial submitted to an Institutional Review Board (IRB) or Independent Ethics Committee
(IEC) for approval, including recruitment and education materials. [Adapted from TMF-RM]; CDISC: Documentation submitted to an Institutional Review Board or Independent Ethics
Committee for approval of the clinical trial, and any changes or updates made to that
trial.;
Origin ID : C115616;
UMLS CUI : C3898749;
Semantic type(s)
- concept_is_in_subset
