Prior Protocol Amendment Indicator

Preferred Label : Prior Protocol Amendment Indicator;

NCIt related terms : Prior Protocol Amendment(s);

Alternative definition : ICH: An indication as to whether the protocol has not been amended, is the first protocol amendment, or a statement that the protocol has been amended previously.;

Codes from synonyms : ICH M11-Section 12;

Details

Origin ID

C218835;

concept_is_in_subset
- ICH M11 Protocol Section 12 Data Element 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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