Index
A
ABLFL variable 139
ADAE (Adverse Event Analysis datasets) 139–141
ADaM (Analysis Data Model)
about 3, 4, 127
ADAE (Adverse Event Analysis dataset) 139–141
ADSL (Subject-Level Analysis dataset) 134–137, 210–213
ADTTE (Time-to-Event Analysis dataset) 141–144
Analysis Results metadata 120–122
Basic Data Structure (BDS) 8, 137–139
considerations 7–8
datasets 200–202
define.xml 117
metadata 117
Pinnacle 21 Community 181
spreadsheets 118–123
tools 128–134
traceability checks 182–184
Variable-Level metadata 118–119
ADAMLIB parameter 183
ADEF (efficacy dataset), creating 137–139
&ADEFKEEPSTRING macro 139
ADSL (Subject-Level dataset) 134–137, 191, 210–213
&ADSLKEEPSTRING macro 136
ADTTE (Time-to-Event Analysis dataset) 141–144
Adverse Event Analysis ...
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