Which visit got more Adverse events?.

Which ARM got more Adverse events?

Concomitant Medication got more visits

Process flow:
Blank CRFs - Annotate CRF - From the annotated CRFs We create SDTM Specification - We map raw
data to SDTM variables - SDTM domains - Compliance check using Pinnacle 21 tool.

SDTM submission package

Define.xml
sdtm in .xpt
SDRG Study data reviewers' guide.
aCRF Annotate CRFs

CT CODELIST - CODED VALUE

Extensible NY - N - NO
Y - YES
NA -NOT APPLICABLE
Non - Exten

Domains
What data would each domain contains(Theory) & Domain structures
What are the common variables that each class share
Inter-relation where ever it exist between domains across all classes

ADaM submission package

CSR Clinical Study Report
ISR Integrated Study Report (ISS + ISE)