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

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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

SLIDE 1

OASIS Electronic Trial Master File Standard Technical Committee

Jan 11 , 2016 9:00 – 9:30 AM PDT Audio from this meeting may be recorded

Minutes and meeting slides

SLIDE 2

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

SLIDE 3

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

SLIDE 4

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

eTMF Standard Update

SLIDE 5

New Business
OASIS Industry Survey – eTMF Standards

New Business

SLIDE 6

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