New Regulatory Guidance Amendment Reason

Preferred Label : New Regulatory Guidance Amendment Reason;

NCIt related terms : New Regulatory Guidance;

Alternative definition : ICH: A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol.;

Codes from synonyms : ICH M11-Reason for Amendment;

Details

Origin ID

C218491;

concept_is_in_subset
- ICH M11 Reason for Amendment Value Set Terminology [NCIt concept]
- ICH M11 Terminology [NCIt concept]
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]

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