Intercurrent Event Strategy
https://w3id.org/m11-rdf/C217344.C188857
- Definition
- A description of the planned strategy to address intercurrent events.
- Namespace
- ICH M11 Section 3 Terminology
- ICH pair
2.16.840.1.113883.3.989.2.3.3.3+C188857(stated in the Technical Specification)- NCIt concept
- http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl#C188857 (EVS identifier)
NCIT_C188857 (OBO PURL) - EVS term
- http://rdf.ich.org/ich-terminology#C217344.C188857 (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 |
|---|---|---|---|---|---|---|---|
| 190 | {<Intercurrent Event Strategy>} | 3.1 Primary Objective(s) and Associated Estimand(s) 3.1.X where X is a unique number for each Primary Objective | Conditional: If there is one or more other intercurrent events as estimand characteristic. | One to one | Text (D) | Yes, repeatable for each intercurrent event relationship | |
| 208 | {<Intercurrent Event Strategy>} | 3.2 Secondary Objective(s) and Associated Estimand(s) 3.2.X where X is a unique number for each Secondary Objective | Conditional: If there is one or more other intercurrent events. | One to one | Text (D) | Yes, repeatable for each intercurrent event relationship | |
| 226 | {<Intercurrent Event Strategy>} | 3.3 Exploratory Objective(s) 3.3.X where X is a unique number for each Exploratory Objective | Conditional: If there is one or more other intercurrent events as estimand characteristic. | One to one | Text (D) | Yes, repeatable for each intercurrent event relationship |
In the ICH M11 Template
| Section | Field | Template | Page | Linked by |
|---|---|---|---|---|
| 3.1.1 Primary Objective 3.1.1 | <Enter Intercurrent Event Strategy> | conditional | p. 28 | ts-term / verb-dropped / section |
Mapping statements to USDM v4
One row per published mapping row that names this element (SSSOM record). The link to the USDM attribute is the mapping publisher's; how the row was tied to this element is in the third column. Paths as given.
| Source | USDM attribute (usdm-rdf) | Identified | Target path | Condition |
|---|---|---|---|---|
| HL7 CSP IG ballot row 144 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| HL7 CSP IG ballot row 145 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| HL7 CSP IG ballot row 146 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
| CDISC DDF-RA v4.0.0 row 148 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85826" |
| CDISC DDF-RA v4.0.0 row 149 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C85827" |
| CDISC DDF-RA v4.0.0 row 150 | IntercurrentEvent-strategy stated: IntercurrentEvent.strategy (attribute name) | by-code | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@intercurrentEvents/IntercurrentEvent/@strategy | StudyVersion/@studyDesigns/StudyDesign/@estimands/Estimand/@variableOfInterest/Endpoint/@id = StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@endpoints/Endpoint/@id | StudyVersion/@studyDesigns/StudyDesign/@objectives/Objective/@level/Code/@code="C163559" |
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.