1. 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

2. 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
Debra Oetzman
Link to project WIKI: