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: UDP Study Title Type Value Set

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/udp-study-title-type-vs | Version: 1.0.0-ballot2 | Highlight text changes?
Standards status: Trial-use Active as of 2026-04-09 | Maturity Level: 2 | Computable Name: UDPStudyTitleTypeVS
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

These codes represent the types of title or name a study can have This is a UDP specific value set using NCIT codes to extend an HL7 value set.

These are codes used in M11 but in the M11 Specification each code is associated with a distinct M11 attribute rather than being a classifier for a more general attribute. FHIR structures are designed to work with a repeating attribute classified by an approriate terminology. This value set enables that. Note that the NCI Thesaurus holds separate codes for protocol name (C132300) that are separate from study title (C49802)

References

- M11 Research Study Profile

### Logical Definition (CLD)

This value set includes codes based on the following rules:

- Import all the codes that are contained in Title Type
- Include these codes as defined in `http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` version 📦1.0.0-ballot2

  Code | Display | Definition
  C207615 | Brief Study Title | The short descriptive name for the study.
  C207646 | Study Acronym | The non-unique initials or abbreviated name used for identification of the study.

### Expansion

Expansion performed internally based on:

- codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)
- codesystem Title Type v1.0.0 (CodeSystem)
- valueset Title Type v1.0.0 (ValueSet)

This value set contains 15 concepts

System | Code | Display (en) | Definition | JSON | XML
`http://terminology.hl7.org/CodeSystem/title-type` | primary | Primary title | Main title for common use. The primary title used for representation if multiple titles exist. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | official | Official title | The official or authoritative title. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | scientific | Scientific title | Title using scientific terminology. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | plain-language | Plain language title | Title using language common to lay public discourse. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | subtitle | Subtitle | Subtitle or secondary title. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | short-title | Short title | Brief title (e.g. 'running title' or title used in page headers) |  |
`http://terminology.hl7.org/CodeSystem/title-type` | acronym | Acronym | Abbreviation used as title |  |
`http://terminology.hl7.org/CodeSystem/title-type` | earlier-title | Different text in an earlier version | Alternative form of title in an earlier version such as epub ahead of print. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | language | Different language | Additional form of title in a different language. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | autotranslated | Different language derived from autotranslation | Machine translated form of title in a different language, language element codes the language into which it was translated by machine. |  |
`http://terminology.hl7.org/CodeSystem/title-type` | human-use | Human use | Human-friendly title |  |
`http://terminology.hl7.org/CodeSystem/title-type` | machine-use | Machine use | Machine-friendly title |  |
`http://terminology.hl7.org/CodeSystem/title-type` | duplicate-uid | Different text for the same object with a different identifier | An alternative form of the title in two or more entries, e.g. in multiple medline entries |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C207615 | Brief Study Title | The short descriptive name for the study. |  |
`http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl` | C207646 | Study Acronym | The non-unique initials or abbreviated name used for identification of the study. |  |

Description of the above table(s).