Clinical Study Protocol (Vulcan UDP)
1.0.1-ballot2 - STU 1 - Ballot International flag

Clinical Study Protocol (Vulcan UDP), published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 1.0.1-ballot2 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/vulcan-udp-ig/ and changes regularly. See the Directory of published versions

ValueSet: Study Amendment Reason Value Set

Official URL: http://hl7.org/fhir/uv/clinical-study-protocol/ValueSet/m11-study-amendment-reason-vs Version: 1.0.1-ballot2
Standards status: Trial-use Draft as of 2025-11-26 Maturity Level: 2 Computable Name: M11StudyAmendmentReasonVS

Codes drawn from NCI Thesaurus to represent the reasons a study was amended.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version Not Stated (use latest from terminology server)
    CodeDisplay
    C218490Regulatory Agency Request To Amend
    C218491New Regulatory Guidance
    C218492IRB/IEC Feedback
    C218493New Safety Information Available
    C218494Manufacturing Change
    C218495IMP Addition
    C218496Change In Strategy
    C218497Change In Standard Of Care
    C218498New Data Available (Other Than Safety Data)
    C218499Investigator/Site Feedback
    C218500Recruitment Difficulty
    C218501Inconsistency And/Or Error In The Protocol
    C218502Protocol Design Error
    C17649Other
    C48660Not Applicable

 

Expansion

This value set contains 1 concepts

SystemCodeDisplay (en)JSONXML
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl  C48660Not Applicable

Description of the above table(s).