PhUSE Key Performance Indicator Initiative CDISC Advisory Council

PhUSE Key Performance Indicator Initiative CDISC Advisory Council

PhUSE Key Performance Indicator Initiative CDISC Advisory Council Feb2018 Scott Bahlavooni PhUSE Working Groups Co-Director Andy Richardson KPI Project Co-Lead PhUSE Mission and Values PhUSE Mission: Provide an welcoming, neutral platform for creating and sharing ideas, implementing data standards, processes, and tools, and exploring

innovative methodologies, techniques, and technologies PhUSE Working Groups Mission: Provide an open, transparent, and collaborative forum in an noncompetitive environment in which Regulators, Life Science Companies, Technology Providers, SDOs, and Academia can address unmet computational science needs impacting product development and regulatory review as to improve human health PhUSE WG Projects: Proposed New Structure Steering Committee Data Transparency

Educating ET&T KPI 1 Number of Projects 45 KPI 3 Nonclnical

KPI 2 ODS Standard Scripts PhUSE KPI Project Overview Established by the PhUSE BoD in Q4, 2016 Objectives:

Create a common set of data reporting metrics to support project reporting and business process management Establish a set standardized KPI terminology and definitions Survey the industry and publish benchmark metrics to support data reporting operations Project co-leads: Yvonne Moore Andy Richardson PhUSE KPI Project Phases

Phase I (Q4, 2016 Q4, 2017): Terms of reference Identification and development of metrics Develop and issue pilot survey Phase II (Q4, 2017+):

Refine and strengthen metrics definitions and documentation Ongoing review of survey results Collate, report, and publish pilot survey results Plan next steps KPI Terminology and Metrics Definitions Study Related ISS Related Submission Related KPI Considerations for CAC/CDISC

CAC Members: Participate in pilot survey Join KPI project and contribute to ongoing activities Increase visibility of KPI project CDISC: Identify and define standards development metrics Identify and define standards implementation metrics Pilot survey to evaluate metrics Increase visibility of KPI project

Questions Scott Bahlavooni - [email protected] Andy Richardson - [email protected]

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