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Learning CenterClinical ProgrammingChapter 1 2

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 1

1.1 The protocol — the contract for the trial 1.2 The Statistical Analysis Plan (SAP)1.3 The Case Report Form (CRF)1.4 CRF annotation (aCRF)1.5 EDC, data flow & database lock

Varun Debbeti

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

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