1. Nonclinical Study Data Reviewers Guide
2018 CSS Project Update

2. Nonclinical Study Data Reviewers Guide
Goals of the project
Maintain and update the nsdrg package provided for public use, incorporating real world feedback and current TCG recommendations
Project status:
Ongoing – developing periodic updates
Project team continuing to work and open for new membership
Ambitions and/or Accomplishments
PhUSE EU 2017 presentation/training session for nsdrg (by Steve Polley)
Plan to issue new updated package in 2018
Develop systematic maintenance and communication practices aligned in principle with csdrg
Update PhUSE public location for finding most current SDRG packages
Link to Project WIKI

3. Nonclinical Study Data Reviewers Guide
Topics of discussion since last nsdrg package update (March 2017) as candidates for update in next version
TCG updates for March 2017, Oct 2017 and March 2018 versions
How much detail should be provided for dataset relationships and supplemental qualifiers – pros/cons
Change of approach on validation rules
Anonymous client feedback to nsdrg providers suggesting to include dates of TCG and nsdrg
CDISC activity on Tumor.xpt v. TM.xpt
Continuity with csdrg

4. Nonclinical Study Data Reviewers Guide
Contacts and Membership
Co-Leads: Debra Oetzman and Sue DeHaven
Membership
Linda Hunt
Christy Kubin
Mark Carfagna
Steve Polley
Rick Thompson
Bill Houser
Florence Halbert
Ken Hershman
Gitte Frausing
Michael Rosentreter
Nicola Robertson
Paul Brown
Matt Whittaker
Maureen Rossi
Tania Smith
Cathy Roy
Jennifer Abbott
Jen Feldmann
Anja Metzger
Susie Lendal
Dan Potenta
If you’d like to join us – contact Debra or Sue!