ICH M11 Protocol Section 1 Data Element Terminology

Preferred Label : ICH M11 Protocol Section 1 Data Element Terminology;

NCIt synonyms : ICH M11-Section 1;

NCIt related terms : ICH M11 Section 1 Terminology;

NCIt definition : Terminology associated with the data elements in section 1 of the ICH M11 protocol template.;

Alternative definition : ICH: Terminology relevant to the data elements in section 1 of the ICH M11 protocol template.;

Details

Origin ID

C217342;

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
- Adaptive Trial Design Indicator [NCIt concept]
- Additional Description of Duration [NCIt concept]
- Age Unit [NCIt concept]
- Alternate Description of Planned Duration of Trial Intervention [NCIt concept]
- Alternate Description of Planned Duration of Trial Participation [NCIt concept]
- Blinding Role [NCIt concept]
- Control Type [NCIt concept]
- Drug/Device Combination Product Indicator [NCIt concept]
- Generic Name [NCIt concept]
- Independent Oversight Committee [NCIt concept]
- International Nonproprietary Name [NCIt concept]
- Intervention Assignment Method [NCIt concept]
- Intervention Model [NCIt concept]
- Master Protocol Indicator [NCIt concept]
- Number of Participants Randomly Assigned to Trial Intervention or Enrolled [NCIt concept]
- Other Committee [NCIt concept]
- Planned Duration of Trial Intervention [NCIt concept]
- Planned Duration of Trial Intervention Unit of Time [NCIt concept]
- Planned Duration of Trial Participation [NCIt concept]
- Planned Duration of Trial Participation Unit of Time [NCIt concept]
- Planned Maximum Age of Subjects [NCIt concept]
- Planned Minimum Age of Subjects [NCIt concept]
- Planned Number of Arms [NCIt concept]
- Planned Subject Number [NCIt concept]
- Population Type [NCIt concept]
- Primary and Secondary Objectives and Estimands Summary [NCIt concept]
- Schedule of Activities [NCIt concept]
- Site Distribution Indicator [NCIt concept]
- Site Geographic Scope Indicator [NCIt concept]
- Study Schematic [NCIt concept]
- Trial Blinding Schema [NCIt concept]
- Trial Indication [NCIt concept]
- Trial Participation Number Target or Maximum Indicator [NCIt concept]
- Trial Schematic Note [NCIt concept]

Keyword's position in hierarchy(ies) :

You can consult :

recommendations
documents concerning education
documents for patients