Optimized SDTM Mapping ProcessZhenglong Tian

Core components

aCRF

Mapping Spec

Define

SDRG/(ADRG)

SDTM/(ADaM)

ARM

Efficiency

Seamless vs chain

MDR

Pinnacle 21

Pinnacle 21

“MDR” concept could be implemented at any step

eDC Raw CSRTFLADaMSDTM

As the nature of our business, we may start our work from any step (not necessarily being outsources E2E. But, “MDR”, “Pattern”, and “Modular” concept can be implemented from any step.

Annotation automation with

JavaDTMS automation Pattern modular Modular macro MW source

validation (VBA/C)

CRF Annotation

Mapping Spec

• Template

• eCRF Spec

• CRF annotation library

Pattern macros

• Date, format, Visit…………….. (Domain/form level, variable level)

Spec Driven auto-programming

Mapping Spec Macro Tool

Program A

Program ….

Program E

Program B

Program D

Program C

Spec driven Define Generation

Mapping Spec Macro Tool Define.xml

Review Guide

• Efficiency Gain Via?