<status value="active"/> <experimental value="false"/> <date value="2026-04-02T08:57:07+00:00"/> <publisher value="HL7 International / Biomedical Research and Regulation"/> <contact> <name value="HL7 International / Biomedical Research and Regulation"/> <telecom> <system value="url"/> <value value="http://www.hl7.org/Special/committees/rcrim"/> </telecom> <telecom> <system value="email"/> <value value="UDP@HL7Vulcan.org"/> </telecom> </contact> <description value="Terminology associated with the trial blinding role value set codelist of the ICH M11 protocol template. This is ICH M11 Value Set C217281 drawn from the NCI Thesaurus and represented here in FHIR format."/> <jurisdiction> <coding> <system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/> <code value="001"/> <display value="World"/> </coding> </jurisdiction> <compose> <include> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <concept> <code value="C17445"/> <display value="Caregiver"/> </concept> <concept> <code value="C70793"/> <display value="Clinical Study Sponsor"/> </concept> <concept> <code value="C25936"/> <display value="Investigator"/> </concept> <concept> <code value="C48660"/> <display value="Not Applicable"/> </concept> <concept> <code value="C207599"/> <display value="Outcomes Assessor"/> </concept> <concept> <code value="C142710"/> <display value="Study Participant"/> </concept> </include> </compose> </ValueSet>

Generated Narrative: ValueSet m11-blinded-roles-vs

Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2

Code	Display	Definition
C17445	Caregiver	The primary person in charge of the care of a patient, usually a family member or a designated health care professional.
C70793	Clinical Study Sponsor	An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. (CDISC Glossary)
C25936	Investigator	An individual who conducts scientific research. In a clinical setting this individual actually conducts and/or supervises the clinical investigation and study-related procedures. The investigator monitors the safety of the trial subjects and investigational staff (under whose immediate direction an agent is administered or dispensed to a subject). The investigator collects and analyses data and study documents, and provides reports in compliance with applicable requirements.
C48660	Not Applicable	Determination of a value is not relevant in the current context.
C207599	Outcomes Assessor	The individual who evaluates the outcome(s) of interest.
C142710	Study Participant	Any individiual that has a role in a study, including study personnel and study subjects.