ICH M11 Protocol Section 11 Data Element Terminology

Preferred Label : ICH M11 Protocol Section 11 Data Element Terminology;

NCIt synonyms : ICH M11-Section 11;

NCIt related terms : ICH M11 Section 11 Terminology;

NCIt definition : Terminology associated with the data elements in section 11 of the ICH M11 protocol template.;

Alternative definition : ICH: Terminology relevant to the data elements in section 11 of the ICH M11 protocol template.;

Détails

Origin ID

C217352;

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
- Clinical Trial Source Data Documentation [NCIt concept]
- Committee Description [NCIt concept]
- Criteria for Early Trial Site Closure [NCIt concept]
- Data Governance [NCIt concept]
- Data Protection [NCIt concept]
- Decision Rights for Trial Site Closure [NCIt concept]
- Description of Assent Process [NCIt concept]
- Description of Emergency Consent Process [NCIt concept]
- Informed Consent Process [NCIt concept]
- Informed Consent Requirements for Rescreening [NCIt concept]
- Informed Consent Requirements for Use of Remaining Samples in Exploratory Research [NCIt concept]
- Insurance and Indemnity Summary [NCIt concept]
- Investigator Expectations for Source Data [NCIt concept]
- Investigator Responsibilities [NCIt concept]
- Protocol Deviation Management [NCIt concept]
- Responsibilities Following Early Trial Site Closure [NCIt concept]
- Risk-Based Quality Management [NCIt concept]
- Sponsor Responsibilities [NCIt concept]
- Study Data Dissemination [NCIt concept]
- Trial Monitor Expectations for Source Data [NCIt concept]
- Trial Oversight Procedure Description [NCIt concept]
- Trial Regulatory and Ethical Consideration [NCIt concept]
- Trial-Related Source Data Description [NCIt concept]

Position du mot-clé dans l'(les) arborescence(s) :

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