clinical-domains

To map raw clinical data to SDTM Events and Interventions domains, apply standard transformation patterns for variable schemas, sequence numbering, and timing logic. This enforces consistent CDISC-compliant dataset structures for regulatory submissions.

SDTM Events domains like AE, DS, and MH capture occurrences, while Interventions domains like CM, EX, and PR capture treatments. Modeling both requires enforcing controlled terminology, ISO 8601 date formatting, and specific validation checks for each domain type.

Enforce ISO 8601 date formatting and controlled terminology by applying standard SDTM transformation rules during domain mapping. This validates timing logic and sequence generation to meet CDISC compliance for events and interventions data.

Yes, you can validate clinical dataset structures for regulatory submissions by applying SDTM domain-level mapping rules. This process checks variable schemas, sequence numbering, and controlled terminology across Events and Interventions domains.

Standard SDTM domain mapping patterns are limited to specific Events like AE, MH, and CE, and Interventions like CM, EX, and SU. They do not cover other SDTM domain classes like Findings or Trial Design without additional specialized transformation rules.