Preferred Label : Institutional Review Board Approval;
NCIt synonyms : IRB Approval;
NCIt related terms : IRB-IEC Approv; approval (in relation to Institutional Review Boards); Institutional Review Board Independent Ethics Committee Approval; IRB-IEC Approval; IRB/IEC Submission Approval;
NCIt definition : A document containing the determination of the Institutional Review Board (IRB) that
the clinical study with human subject participation has been reviewed and may be conducted
at a particular study site within the constraints set forth by the IRB and other institutional
and federal requirements. The regulations require that an IRB conduct continuing review
of research at intervals appropriate to the degree of risk, but not less than once
a year.;
Alternative definition : CareLex: Study Site specific document containing the determination of the Institutional
Review Board (IRB) or Independent Ethics Committee (IEC) that the clinical study with
human subject participation has been reviewed and may be conducted at a particular
study site within the constraints set forth by the IRB and other institutional and
federal requirements. [NCI]; CDISC-GLOSS: The affirmative decision of the IRB that the clinical trial has been
reviewed and may be conducted at the institution site within the constraints set forth
by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory
requirements. [ICH E6];
Origin ID : C70800;
UMLS CUI : C2346499;
Semantic type(s)
- concept_is_in_subset
