OASIS Electronic Trial Master File Standard Technical Committee - PowerPoint PPT Presentation

Minutes and meeting slides OASIS Electronic Trial Master File Standard Technical Committee Jan 11 , 2016 9:00 – 9:30 AM PDT *Audio from this meeting may be recorded*

Agenda Topic Presenter 9:00 - 9:05 Call to Order Chair 9:05 - 9:10 Roll Call Chair 9:10 – 9:12 OASIS eTMF Standard update Chair 9:40 – 9:50 New Business All 9:50 – 9:55 Agenda – next meeting All 2

Roll Call - Present Name Company Status Aliaa Badr CareLex Member Oleksiy (Alex) Palinkash CareLex Member Troy Jacobson Forte Research Systems Member Peter Alterman SAFE-BioPharma Association Member Catherine Schmidt SterlingBio Member Ayrat Sadreev SureClinical Member Zack Schmidt, Chair SureClinical Member Trish Whetzel SureClinical Member

eTMF Standard Update Accomplished – • CDISC update • Nat Cancer Institute (NCI) – Enterprise Vocab Services terms submission Next Steps - – Spec update » Waiting for NCI to finalize and publish new terms in global database – NCI Thesaurus

New Business • New Business • OASIS Industry Survey – eTMF Standards

Next Meeting(s) Agenda / Close • Next general OASIS eTMF TC Meeting date: – Next TC meeting: – Feb 1 2016 9am-10.00am PT • NCI Thesaurus – term publication status • Committee draft spec publication • New business