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Learning CenterClinical ProgrammingChapter 8 5

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 8

8.1 The safety data landscape 8.2 SAE processing & reconciliation 8.3 DMC / DSMB deliverables 8.4 Safety Review Committees (SRC) & signal detection 8.5 Aggregate safety reports 8.6 Deaths, SAEs & narratives feed

Varun Debbeti

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

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