CDISC Implementation Primer PhUSE Working Group Projects & - - PowerPoint PPT Presentation

PhUSE Working Group Projects & Collaborations 28 February 2018 Co-Leads: Scott Bahlavooni (PhUSE) Peter Van Reusel (CDISC)

CDISC Implementation Primer

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
• Data Managers

è Implement

• Clinicians
• Statisticians

è Review

• Business Leaders
• Stakeholders

è Decide

• Regulated

Research

• Academia
• Non-Clinical
• Nutrition
• Cosmetics
• …

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
• …

èUse 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?