New Regulatory Guidance

Preferred Label : New Regulatory Guidance;

Alternative definition : CDISC: A regulatory agency has published a guidance document that necessitates a change(s) to, or formal clarification of, the protocol. (ICH M11);

Details

Origin ID

C207608;

concept_is_in_subset
- CDISC DDF Study Amendment Reason Code Value Set Terminology [NCIt concept]
- CDISC DDF Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

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