Sensitivity Analysis
https://w3id.org/m11-rdf/C217351.C218480
- Definition
- A description of the series of analyses conducted to explore the robustness of inferences from the main estimator to deviations from its underlying modeling assumptions and limitations in the data.
- Namespace
- ICH M11 Section 10 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.10+C218480(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C218480 (EVS identifier)
NCIT_C218480 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217351.C218480 (EVS term IRI; does not resolve)
- Label from
- ICH M11 Terminology, NCI EVS, release 2025-12-19
Specifications in the Technical Specification
One row per component block of Appendix 1 that names this element. Text as printed.
| Block | Term | Section | Conformance | Cardinality | Data type | Value code list | Repeating / reuse |
|---|---|---|---|---|---|---|---|
| 475 | {<Sensitivity Analysis>} | 10.4 Analyses Associated with the Primary Objective(s) 10.4.X.4 | Conditional: when there is Sensitivity Analysis for a Primary Objective | One to many | Text (D) | Yes, repeatable for each objective as a series of level 4 sections (10.4.X.1, 10.4.X.2, 10.4.X.3, 10.4.X.4, 10.4.X.5). | |
| 487 | {<Sensitivity Analysis>} | 10.5 Analyses Associated with the Secondary Objective(s) 10.5.X.4 | Conditional: when there is Secondary Objective and Sensitivity Analysis for a Secondary Objective | One to one | Text (D) | Yes, repeatable for each objective as a series of level 4 sections (10.5.X.1, 10.5.X.2, 10.5.X.3, 10.5.X.4, 10.5.X.5). |
In the ICH M11 Template
The Template heading of 10.4.1.4 Sensitivity Analysis, 10.5.1.4 Sensitivity Analysis is this element.
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 10.4.1.4 Sensitivity Analysis 10.4.1.4 | <Enter Sensitivity Analysis> | conditional | p. 56 | ts-term / verb-dropped / section |
| 10.5.1.4 Sensitivity Analysis 10.5.1.4 | <Enter Sensitivity Analysis> | conditional | p. 57 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
None: no row of the two pinned mappings is identified with this element and resolves in USDM v4.0.0.
Draft, not normative. A derived rendering of the ICH M11 Technical Specification, Template, code lists and OID Listing (© ICH, used under the ICH Legal Mentions) and of the ICH M11 Terminology published by NCI EVS (CC BY 4.0). Not an ICH, CDISC or HL7 artifact, and not endorsed or sponsored by ICH.