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Learning CenterClinical ProgrammingChapter 6 4

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 6

6.1 TLF fundamentals 6.2 Demographics & baseline characteristics 6.3 Disposition 6.4 Exposure & treatment compliance 6.5 Concomitant medications 6.6 Efficacy — primary, secondary & exploratory endpoints 6.7 Safety — adverse events 6.8 Safety — labs, vitals & ECG 6.9 Listings & figures

Varun Debbeti

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

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