Index
A
Access files
See Microsoft Office files
ACDM (Association for Clinical Data Management) 250, 251
ADaM (Analysis Data Model) 5, 73, 83
Adobe PDF files 167–168
adverse events
about 31–32
concomitant medication 33
creating summaries 22, 130–139
laboratory data 34
serious adverse events (SAE) 33
treatment-emergent signs and symptoms (TESS) 32
American Statistical Association 251
analyses of clinical data
correlation coefficients 226
descriptive statistics 216–218
inferential statistics 218–225
statistical analysis plan (SAP) 11
time-to-event analysis statistics 225
Analysis Data Model (ADaM) 5, 73, 83
Analysis Data Model and ADaM Implementation Guide 105, 108
analysis data sets
about 71–72
categorical data 90–93
change-from-baseline 105–108 ...
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