1
Presented on behalf of PhUSE Working Group 4: Helena Sviglin (FDA), Douglas Warfield (FDA), Steve Wilson (FDA), John Brega (PharmaStat), Joanna KoH (Biogen Idec), Gail Stoner (J&J), ScoL Bahlavooni (Genentech), and David Brega (PharmaStat) PhUSE Working Group 4 developed an SDTM Study Data Reviewers Guide (SDRG) template to supplement the informaCon found in define.xml for drug submissions. This sample Study Data Reviewer's Guide document illustrates the intended use of the template and demonstrates what a finished document should look like. • This template was produced with FDA parCcipaCon. • A reviewers guide is not required for SDTM submissions yet, but could be in the future. • This template is openNended. It supports many possible study data scenarios. • The quesConnaire format gives the finished SDRG a consistent look and feel, to help reviewers find the informaCon they need. • Weve started the document for you, you just have to fill it out! •This reviewers guide fills in gaps in current submission documentaCon. •The design and tesCng of this package may inform future documentaCon standards. •Include your SDRG in Module 5 of the eCTD with the studys SDTM datasets.
![Implementation of CDISC Standards at Nycomed - PhUSE PAPERS/RG05 [Compatibility Mode].pdf · Implementation of CDISC Standards at Nycomed PhUSE, Basel ... .xpt Define.xml SAS NYC](https://static.documents.pub/doc/80x56/5ab32f9f7f8b9a6b468e31e2/implementation-of-cdisc-standards-at-nycomed-papersrg05-compatibility-modepdfimplementation.jpg)
