IntercurrentEvent
https://kerfors.github.io/usdm-overlay/id/assessment/classRole/IntercurrentEvent
Overlay page for the USDM class https://w3id.org/cdisc/usdm/v4/IntercurrentEvent.
Role
- role
- Templated text
- evidence
- Model-stated
- basis
- rule-role-templated-text
- superclass
- SyntaxTemplate
Profile
Attributes of the class and its superclasses; payload excludes housekeeping, naming and notes.
- has naming
- true
- is referenced
- false
- composed in (classes)
- 1
- read text
- 2
- string structure
- 0
- value
- 0
- reference
- 1
- part
- 0
Attributes declared on this class
Inherited attributes are listed on SyntaxTemplate.
| Attribute | Range | Content kind | Evidence | Rule or rationale |
|---|---|---|---|---|
| extensionAttributes | ExtensionAttribute | Extension point | Model-stated | rule-extension-point |
| instanceType | string | Type discriminator | Model-stated | rule-type-discriminator |
| strategy | string | Classification as text derived: Unclassified string | Authored | ICH E9(R1) names a fixed set of strategies for intercurrent events, so the substance is a classification. The definition asks for a textual description and USDM_CT.xlsx gives no value list. Classified by substance; the conflict is recorded as finding intercurrent-event-strategy-textual.A textual description of the planned strategy to manage and/or mitigate intercurrent events. |