• Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2

  Code	Display	Definition
  C218497	Change in Standard Of Care Amendment Reason	A change in the standard of care necessitates a change(s) to, or formal clarification of, the protocol.
  C218496	Change in Strategy Amendment Reason	A change in the study purpose or intent of the scientific plan necessitates a change(s) to, or formal clarification of, the protocol.
  C218495	IMP Addition Amendment Reason	The addition of an investigational medicinal product to a clinical trial design necessitates a change(s) to, or formal clarification of, the protocol.
  C218501	Inconsistency and/or Error in the Protocol Amendment Reason	An error or inconsistency in the protocol necessitates a change(s) to, or formal clarification of, the protocol.
  C218499	Investigator/Site Feedback Amendment Reason	Feedback from the investigator or study site necessitates a change(s) to, or formal clarification of, the protocol.
  C218492	IRB/IEC Feedback Amendment Reason	Feedback from the institutional review board or independent ethics committee necessitates a change(s) to, or formal clarification of, the protocol.
  C218494	Manufacturing Change Amendment Reason	A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.
  C218498	New Data Available (Other Than Safety Data) Amendment Reason	Previously unavailable data (other than safety data) becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
  C218491	New Regulatory Guidance Amendment Reason	A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.
  C218493	New Safety Information Available Amendment Reason	Previously unavailable safety data becomes available, which necessitates a change(s) to, or formal clarification of, the protocol.
  C48660	Not Applicable	Determination of a value is not relevant in the current context.
  C17649	Other	Different than the one(s) previously specified or mentioned.
  C218502	Protocol Design Error Amendment Reason	A protocol design error necessitates a change(s) to, or formal clarification of, a document.
  C218500	Recruitment Difficulty Amendment Reason	Challenges with participant recruitment necessitates a change(s) to, or formal clarification of, the protocol.
  C218490	Regulatory Agency Request to Amend Amendment Reason	A regulatory agency has expressed a need for a change(s) to, or formal clarification of, the protocol.

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

This value set contains 15 concepts