Nonclinical Study Data Reviewers Guide

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Presentation transcript:

Nonclinical Study Data Reviewers Guide 2018 CSS Project Update

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

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

Nonclinical Study Data Reviewers Guide Contacts and Membership Co-Leads: Debra Oetzman (debra.oetzman@instem.com) and Sue DeHaven (susan.dehaven@sanofi.com) Membership Linda Hunt linda.hunt@merck.com Christy Kubin christy.kubin@mpiresearch.com Mark Carfagna carfagna_mark_a@lilly.com Steve Polley steven.r.polley@gsk.com Rick Thompson rthompso@its.jnj.com Bill Houser william.houser@bms.com Florence Halbert florence.halbert@novartis.com Ken Hershman kenneth.hershman@novartis.com Gitte Frausing gfrausing@datastandardsdecisions.com Michael Rosentreter michael.rosentreter@bayer.com Nicola Robertson nicola.j.robertson@gsk.com Paul Brown paul.brown@fda.hhs.gov Matt Whittaker matthew.whittaker@fda.hhs.gov Maureen Rossi maureen.rossi@roche.com Tania Smith tania.strimple@covance.com Cathy Roy catherine.roy@merck.com Jennifer Abbott jennifer.abbott@abbvie.com Jen Feldmann jennifer.feldmann@epreda.com Anja Metzger anja.metzger@bayer.com Susie Lendal slendal@datastandardsdecisions.com Dan Potenta dan.potenta@pdslifesciences.com If you’d like to join us – contact Debra or Sue!