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Project Scope

Best Practices in Data Standards Implementation Governance will cover the following areas:

Building and maintaining the contents of data standards repositories.
Extending data standards for individuals projects/studies.
Maintaining Sponsor extensions to data standards.
Scope of data standards governance:
- What areas should be covered by governance? (e.g. CRF, external data, tabulation, analysis, RWE, etc…).
- What should be governed centrally vs permitted on studies?
Feedback/communication to/with SDOs.

Project Leads	Email
Ellen Asam	ellen_asam@merck.com
Sandy VanPelt Nguyen	sandra.vanpeltnguyen@pfizer.com
Katie Warren (PHUSE Project Assistant)	katie@phuse.global

Objectives & Deliverables	Timelines
Build surveySurvey	Q12022Q1 2022
Distribute survey to public	Q12022
Summarise Summarise survey results in a White Paper	Q2/32022	Plan to submit poster for CSS	Q320223 2022
Poster at PHUSE/FDA CSS	Q3 2022
Publish White Paper	Q1 2023

Status

colour	Blue
title	Current Status

Q12022

Survey was released to the public.

Started drafting introductory sections of White Paper.

Q2/3 2022

Project Members	Organisation
Aimee Basile	Surface Oncology
Brook (Amanda) Hinkson	Merck
Carlo Radovsky	Immanant
Cathy Yang	Roche
Gayathri Mahadevan	Cytel
Gina Wood	eClinical Solutions
Jennifer Jarvis	Eli Lilly
Junying Zhang	Gilead
Kapil Anand	Parexel
Ligia Kilinski Cevasco	Jazz Pharmaceuticals
Matt Baldwin	Amgen
Parisa Osivand Pour	Industry
Patrick Genyn	Janssen Research and Development
Ranvir Singh	Labcorp
Rie Ichihashi	Sanofi
Rony Ye	EBSI
Sathesh Avvaru	PPD
Tingting Tian	Regeneron
Titania Dumas-Roberson	Unither Pharmaceuticals
Todd Bazin	Biogen
Torsten Petsching	Boehringer Ingelheim

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