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cdisc-data-handling

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Reads, validates, and prepares CDISC SDTM and ADaM clinical trial data for analysis. Covers SDTM domain joins (DM, AE, EX, VS, LB, DS), ADaM architecture (ADSL, BDS, OCCDS, ADTTE) with traceability, treatment-emergent AE conventions, baseline derivation, SUPPQUAL/NSV handling, Define-XML 2.1, and Pinnacle 21 / CORE validation. Use when working with clinical trial datasets in CDISC SDTM/ADaM format, preparing analysis-ready data, or validating for regulatory submission.

When to use

• Reading CDISC SDTM domain files
• Building or consuming ADaM analysis-ready datasets
• Validating data for regulatory submission
• Handling SDTM domain joins (DM, AE, EX, VS, LB, DS)
• Managing ADaM architecture (ADSL, BDS, OCCDS, ADTTE)
• Applying treatment-emergent AE conventions
• Deriving baseline values
• Handling SUPPQUAL/NSV and Define-XML 2.1

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