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Found 2 Skills
Reason about CDISC SDTM and ADaM implementation for regulatory submissions. Use when the user asks about SDTM domain mapping, ADaM dataset design, controlled terminology versioning, define.xml completeness, FDA or PMDA submission requirements, query prioritization by clinical impact, SUPPQUAL usage, or CDISC compliance review. Triggers include "SDTM mapping", "ADaM dataset", "CDISC compliance", "controlled terminology", "define.xml", "FDA submission data", "PMDA submission", "SDTM domain", "ADSL", "ADAE", "ADLB", "BDS structure", "SUPPQUAL", "RELREC", "value-level metadata", "CDISC CT", "regulatory submission data standards", "eCTD datasets", "SDTM 3.3", "ADaM 1.1", "query prioritization", "clinical data review".
Generate code for EDC export validation, clinical data range checks, cross-form consistency checks, SDTM structure validation, controlled terminology verification, and define.xml generation. Use when the user asks to validate clinical trial data exports, check vital sign or lab value ranges, verify AE date consistency, validate SDTM datasets against CDISC rules, generate define.xml, or build an automated data review pipeline. Triggers include "EDC validation", "range check clinical data", "cross-form consistency", "SDTM validation", "controlled terminology check", "define.xml generation", "Medidata Rave export", "Oracle InForm", "Veeva Vault CDMS", "clinical data cleaning", "edit check", "data query", "SDTM structure check", "lab range check", "vital signs validation", "AE date check", "protocol deviation detection", "OpenCDISC", "Pinnacles 21", "P21 validation".