Clinical Study Protocol
1.0.0-ballot2 - STU 1 Ballot2

Clinical Study Protocol - Downloaded Version 1.0.0-ballot2 See the Directory of published versions

## ValueSet: ICH M11 Trial Blinding Role Value Set Terminology

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-blinded-roles-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 0 | Computable Name: M11BlindedRolesVVS
Copyright/Legal: Portions of this material derives from the ICH M11 Harmonised Guideline CeSHarP. The ICH M11 Harmonised Guideline CeSHarP is copyright ©2025+ International Committee on Harmonisation and is made available under license. CDISC publishes semantics for the ICH M11 protocol data elements and valid value sets. This terminology set is published and stored in the NCI Thesaurus Subset C217023 - ICH M11 Terminology (https://evsexplore.semantics.cancer.gov/evsexplore/subset/ncit/C217023) The NCI Thesaurus is released under the CC BY 4.0 license For more licensing information and links see: licenses.html

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.

References

This value set is not used here; it may be used elsewhere (e.g. specifications and/or implementations that use this content)

### Logical Definition (CLD)

- 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.

### Expansion

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 6 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C17445 | Caregiver | The primary person in charge of the care of a patient, usually a family member or a designated health care professional. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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) |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | 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. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C48660 | Not Applicable | Determination of a value is not relevant in the current context. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C207599 | Outcomes Assessor | The individual who evaluates the outcome(s) of interest. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C142710 | Study Participant | Any individiual that has a role in a study, including study personnel and study subjects. |  |

Description of the above table(s).