Intercurrent event strategy: fixed set, specified as text
https://kerfors.github.io/usdm-overlay/id/finding/intercurrent-event-strategy-textual
IntercurrentEvent.strategy is defined as a textual description and has no value list. ICH E9(R1), section A.3.2, names five strategies: treatment policy, hypothetical, composite variable, while on treatment, principal stratum. The overlay classifies the attribute as classification as text; read by its definition alone it would be prose.
- standing
- For discussion: The gap to ICH E9(R1) is plain, but asking for a value list is a modelling request.
- rationale
- The substance is one of a fixed set named by the guideline, possibly with explanation. Classifying by substance shows where a value list could carry meaning that the model holds as text.
- evidence
- Authored
- holds
- true
- observation
- C188857 Intercurrent Event Strategy: A textual description of the planned strategy to manage and/or mitigate intercurrent events. Has Value List N.
- about
- IntercurrentEvent
- sources
- https://github.com/cdisc-org/DDF-RA/blob/v4.0.0/Deliverables/CT/USDM_CT.xlsx
https://www.ema.europa.eu/documents/scientific-guideline/ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical-principles_en.pdf
Test
Check function intercurrent_event_strategy_textual in scripts/check_findings.py.