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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