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Implementing CDISC Using SAS by Jack Shostak, Chris Holland

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Index

A

ABLFL variable 130

ADAE (Adverse Event Analysis datasets) 131–132

ADaM (Analysis Data Model)

about 3, 4, 117

ADAE (Adverse Event Analysis dataset) 131–132

ADSL (Subject-Level Analysis dataset) 125–128, 176, 190–192

ADTTE (Time-to-Event Analysis dataset) 133–136

Analysis Results metadata 110–113, 233

Basic Data Structure (BDS) 10, 128–130

Codelist metadata 232

Computational Method metadata 231

considerations 8–11

datasets 183–185

Define Header metadata 229

define.xml 107–108

External Links metadata 233

metadata 107–108

OpenCDISC Validator 150–167

Parameter-Level metadata 231

published validation checks 163

spreadsheets 108–113

Table of Contents metadata 229

tools 118–124

traceability checks 167–170

Variable-Level metadata 108–109, 230–231 ...

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