CDISC Implementation Primer PhUSE Working Group Projects & Collaborations 28 February 2018 Co-Leads: Scott Bahlavooni (PhUSE) Peter Van Reusel (CDISC)
CDISC Implementation Primer Project Leads: Scott Bahlavooni - PhUSE & Peter Van Reusel – CDISC Opportunity: New CDISC implementers can be overwhelmed by the myriad of information • available related to CDISC landscape including the CDISC standards, regulatory requirements, implementation best practices, etc. Project Goals: Identify the needs of new CDISC implementers • Provide a publicly available, centralized starting point for newcomers to • quickly access and digest information related to the CDISC standards implementation
Project Opportunity • CDISC Newcomers are overwhelmed by information – CDISC Data Standards – Regulatory Requirements – Implementation Practices – … Where to Start learning? • Where to start implementing • What is important? • What do I need to know first? •
Target Audience • Programmers • Regulated Research • Data Managers • Academia è Implement • Non-Clinical • Clinicians • Nutrition • Statisticians • Cosmetics è Review • … • Business Leaders • Stakeholders è Decide
Project Goals • Identify the needs of CDISC newcomers – Who are the newcomers? – What information do they need? – How can we point them to this Primer? • Provide a starting point, a ‘Primer’ – Publicly available, free – Centralized, Quickly accessible – Provide an overview
What information is needed? • Introduction to CDISC • Overview of CDISC data standards • Implementation options & examples • Regulatory Requirements • Best Practices • … è Use survey to reach “out of industry” e.g. Academic, Medical Devices, Nutritional, Cosmetic, …
How to assemble the Primer • Existing materials – Bring information together – Digestable, layers of details • New Materials – Wiki page – Slide decks – Online video / intro courses – Infomercial / flyers – …
Where to find the Primer • How do we guide newcomers to the Primer – Social Media – Website – Conferences / presentations – Published by PhUSE & CDISC – Industry consortia – …
Where to find the Primer • How can we bring awareness to the Primer • Who can help us promote? • How can we reach new geographic markets?
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