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Learning CenterClinical ProgrammingChapter 4 6

0The Clinical Trial Landscape 1From Protocol to Data 2Programming Foundations for Clinical Work 3CDISC Standards 4Building SDTM 5Building ADaM 6Tables, Listings & Figures (TLFs)7Statistics for Programmers 8Safety & Pharmacovigilance 9Medical Writing & Regulatory Deliverables 10Regulatory Submission 11Capstone: A Phase 3 Trial, End to End

Module 4

4.1 From aCRF to SDTM — the mapping mindset 4.2 Special-purpose & demographics: DM 4.3 Interventions domains: EX, CM, (EC)4.4 Events domains: AE, MH, DS 4.5 Findings domains: LB, VS, EG 4.6 Trial-design & relationship datasets 4.7 Validating SDTM

Varun Debbeti

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PhUSE & Industry:PhUSE 2018 / SI12 PhUSE 2020 / DS03 PHUSE Blog / USDM, ARS & CORE Connect

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