Nonclinical SDRG Goals of the project Project status: Ambition: Maintain the nSDRG package (Guideline, Template, Examples) as a harmonized public resource, adhering to the FDA Tehnical Conformance Guide recommendations, while considering public and regulatory input. Project status: Team active and plans to continue through coming year. Project co-lead, Laura Kaufmann has decided to step down, to redirect energies toward CDISC Animal Rule initiative Ambition: Continue the team’s work, addressing the new Standards, Guidance and evolving concepts Develop examples for new study types (i.e. Safety Pharm) Address topics of continued “interest’ such as: DEFINE validation outcomes, Legacy Data Conversion section, ongoing Package vertsion management

Nonclinical SDRG Accomplishments Contacts Link to project WIKI: Package UPDATED based on Public Review and FDA Feedback in 2016 published to the SDRG site on PhUSE WIKI nSDRG Completion Guidelines v1.1 nSDRG Template v1.1 Contacts Sue DeHaven susan.dehaven@sanofi.com Debra Oetzman debra.oetzman@instem.com Link to project WIKI: http://www.phusewiki.org/wiki/index.php?title=Nonclinical_Study_Data_Reviewers_Guide