Pharmaceutical Research 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 1.0.0-ballot 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
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
http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
Code | Display |
C218490 | Regulatory Agency Request To Amend |
C218491 | New Regulatory Guidance |
C218492 | IRB/IEC Feedback |
C218493 | New Safety Information Available |
C218494 | Manufacturing Change |
C218495 | IMP Addition |
C218496 | Change In Strategy |
C218497 | Change In Standard Of Care |
C218498 | New Data Available (Other Than Safety Data) |
C218499 | Investigator/Site Feedback |
C218500 | Recruitment Difficulty |
C218501 | Inconsistency And/Or Error In The Protocol |
C218502 | Protocol Design Error |
C17649 | Other |
C48660 | Not Applicable |
This value set contains 1 concepts
Code | System | Display (en-US) |
C48660 | http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl | Not 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 |