ICH M11 Reason for Amendment Value Set Terminology

Preferred Label : ICH M11 Reason for Amendment Value Set Terminology;

NCIt synonyms : ICH M11-Reason for Amendment;

NCIt related terms : Reason for Amendment Response Terminology;

NCIt definition : Terminology associated with the reason for amendment value set codelist of the ICH M11 protocol template.;

Alternative definition : ICH: A valid value set relevant to the reason for amendment responses within the ICH M11 protocol template.;

Details

Origin ID

C217276;

concept_is_in_subset
- ICH M11 Terminology [NCIt concept]
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Terminology [NCIt concept]
subset_includes_concept
- Change in Standard Of Care Amendment Reason [NCIt concept]
- Change in Strategy Amendment Reason [NCIt concept]
- IMP Addition Amendment Reason [NCIt concept]
- IRB/IEC Feedback Amendment Reason [NCIt concept]
- Inconsistency and/or Error in the Protocol Amendment Reason [NCIt concept]
- Investigator/Site Feedback Amendment Reason [NCIt concept]
- Manufacturing Change Amendment Reason [NCIt concept]
- New Data Available (Other Than Safety Data) Amendment Reason [NCIt concept]
- New Regulatory Guidance Amendment Reason [NCIt concept]
- New Safety Information Available Amendment Reason [NCIt concept]
- Not Applicable [NCIt concept]
- Other [NCIt concept]
- Protocol Design Error Amendment Reason [NCIt concept]
- Recruitment Difficulty Amendment Reason [NCIt concept]
- Regulatory Agency Request to Amend Amendment Reason [NCIt concept]

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