Manufacturing Change Amendment Reason

Preferred Label : Manufacturing Change Amendment Reason;

NCIt related terms : Manufacturing Change;

Alternative definition : ICH: A change to manufacturing processes of the study agents necessitates a change(s) to, or formal clarification of, the protocol.;

Codes from synonyms : ICH M11-Reason for Amendment;

Details

Origin ID

C218494;

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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