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Learning CenterClinical ProgrammingChapter 5 7

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 5

5.1 ADaM principles in practice 5.2 ADSL — the subject-level spine 5.3 BDS I — ADVS (vital signs)5.4 BDS II — ADLB (labs)5.5 OCCDS — ADAE 5.6 ADTTE — time-to-event 5.7 ADaM define & validation

Varun Debbeti

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

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