cdisc-org / cdisc-org/cdisc-rules-engine
As VALIDATOR, I want to cross-check dataset variable against individual WHODrug components so that I can stay compliant with SD1344, SD1345, SD1346
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Define-XML cross check
FDA Validator Rules
- Dominant language
- Python
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Description
1. This check only applies to SDTM and SEND data.
2. This check is IG-version-agnostic.
3. This check takes the WHODrug version from the define.xml.
SD1344 in FDA VR v1.6:
- Rule message: Value for --DECOD not found in WHODrug dictionary
- Rule description: Value for the Standardized Medication Name (--DECOD) variable must be populated using a Drug Name from the WHO Drug dictionary version specified in the define.xml.
Relationship between variable and WHODrug component:
- SD1344: --DECOD against Drug Name
- SD1345: --CLAS against ATC Text
- SD1346: --CLASCD against ATC Code
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