PDF CDISC Public Webinar Series - ADaM Implementation Guide ...

CDISC Public Webinar Series ADaM Implementation Guide version 1.2 Public Review

23 January 2018

? CDISC 2018

Strength through Collaboration

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Panelists

? Brian Harris, Director of Biometrics Operations, MedImmune ? Terek Peterson, Senior Director, Global Statistical Standards, Covance ? Nancy Brucken, Principal Statistical Programmer, Syneos Health Clinical

Solutions ? Tara Erb, Research Scientist Statistician, Eli Lilly & Co. ? Nate Freimark, VP, Clinical Programming and Data Standards, The Griesser

Group ? Isaac Swanson, Data Standards Consultant, Eli Lilly & Co ? Richann Watson, CDISC Subject Matter Expert ? Alyssa Wittle, Senior Biostatistician, Covance

? CDISC 2018

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Question & Answer

? `Panelist': Question OR ? `Presentation': Question

Examples:

1) What should be supported by ADaM datasets? 2) Jack: Is there a limit to the number of variables

that can be in ADSL?

? CDISC 2018

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Content Disclaimer

All content in this presentation is for education and information only. References to any specific commercial product, process, service, or corporation are also for information only, and do not constitute endorsement, recommendation, or favoring by CDISC or the CDISC community.

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? CDISC 2018

History of ADaMIG Versions

? ADaMIG v1.0 released late 2009

Two structures outlined

? ADSL ? BDS ? Supplemental parameters added for ADaM analysis datasets

BDS TTE v1.0 released mid- 2012 ADAE v1.0 released mid-2012

? ADaMIG v1.1 released early 2016

Concurrently created is a third analysis data structure

? OCCDS v1.0

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