Brief Explanation of Substantial Impact on Participant Safety

Preferred Label : Brief Explanation of Substantial Impact on Participant Safety;

NCIt related terms : Briefly Explain Substantial Impact On Safety;

Alternative definition : ICH: A short descriptive account of any substantial impacts on the safety or rights of the participants due to the protocol amendment.;

Codes from synonyms : ICH M11-Section Amendment Details;

Details

Origin ID

C218699;

concept_is_in_subset
- ICH M11 Protocol Section Amendment Details 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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