ICH M11 Protocol Section 9 Data Element Terminology

Preferred Label : ICH M11 Protocol Section 9 Data Element Terminology;

NCIt synonyms : ICH M11-Section 9;

NCIt related terms : ICH M11 Section 9 Terminology;

NCIt definition : Terminology associated with the data elements in section 9 of the ICH M11 protocol template.;

Alternative definition : ICH: Terminology relevant to the data elements in section 9 of the ICH M11 protocol template.;

Details

Origin ID

C217350;

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
- Adverse Event of Special Interest [NCIt concept]
- Causality [NCIt concept]
- Definition of Adverse Events [NCIt concept]
- Definition of Medical Device Product Complaints [NCIt concept]
- Definition of Product Complaints [NCIt concept]
- Definition of Serious Adverse Events [NCIt concept]
- Disease-related Events or Outcomes Not Qualifying as Adverse Events or Serious Adverse Events [NCIt concept]
- Event Collection and Reporting Timing Description [NCIt concept]
- Event Follow-up Procedure Description [NCIt concept]
- Event Recording Procedure Description [NCIt concept]
- Event Reporting Procedure Description [NCIt concept]
- Participants Who Become Pregnant During the Trial Data Collection [NCIt concept]
- Participants Whose Partners Become Pregnant During the Trial Data Collection [NCIt concept]
- Regulatory Reporting Requirements for Trial-Related Events [NCIt concept]
- Reportable Period End Date [NCIt concept]
- Reportable Period Start Date [NCIt concept]
- Safety Event Situational Scope Description [NCIt concept]
- Severity [NCIt concept]
- Special Safety Situation Type [NCIt concept]
- Timing Description for Reporting to Sponsor or Designee [NCIt concept]
- Trial Event Back-Up Reporting Method [NCIt concept]
- Trial Event Reporting Method [NCIt concept]
- Trial-Related Event Identification [NCIt concept]
- Trial-Related Safety Event Type [NCIt concept]

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