" /> TMF-RM IRB or IEC Trial Approval Section - CISMeF





Preferred Label : TMF-RM IRB or IEC Trial Approval Section;

NCIt related terms : IRB-IEC Doc Subcat; IRB/IEC Trial Approval; Institutional Review Board Independent Ethics Committee Documents; IRB-IEC Documents Subcategory; IRB or IEC Trial Approval;

NCIt definition : The Trial Master File Reference Model section that contains a collection of documents related to the Institutional Review Board or Independent Ethics Committee decisions for the clinical trial.;

Alternative definition : CareLex: Subcategory name for the eTMF domain containing documentation between an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) and a Study Site regarding human subjects in biomedical or behavioral research.; CDISC: A collection of documents related to the Institutional Review Board or Independent Ethics Committee decisions for the clinical trial.;

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Keyword's position in hierarchy(ies) : arborescence

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10/07/2025


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