Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

ValueSet: Study Amendment Reason Value Set

Official URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-study-amendment-reason-vs Version: 1.0.0-ballot
Standards status: Trial-use 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
    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

CodeSystemDisplay (en-US)
  C48660http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owlNot Applicable

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code