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Sub Project Overview

The Optimizing the Use of Data Standards CSS working group has defined Best Practices as a current project. Two of the topics identified in 2014 are related to EPOCH and VISITNUM. The goal of our sub-project is to develop a set of recommendations for best practices in defining, deriving, and implementing the assignment of values to these variables at a subject level.

Final White Paper

Final VISITNUM and EPOCH White Paper

Project Leads

Name Role Organization E-mail
Natalia Smeljanski Team Lead Merck Natalia.Smeljanski [at]
Ronald Fitzmartin FDA Liaison FDA Ronald.Fitzmartin [at]
Helena Sviglin FDA Liaison FDA Helena.Sviglin [at]

Project Members

Name Organization E-mail
Dennis Ballinger SCRI Development Innovations Dennis.Ballinger [at]
Hongfei Guo Merck Hongfei.Guo [at]
Tatyana Kovtun Bayer Tatyana.Kovtun [at]
Jane Lozano Lilly Lozano_Jane_A [at]
Trevor Mankus Shire TMankus [at]
Carol Vaughn Sanofi US Carol.Vaughn [at]

Objectives and Timelines

TC# Date Objective Minutes Taker
1 2014-04-08 Need to agree on chapters. Start User cases. Carol Vaughn
2 2014-04-22 Final agreement at scope section. All cases are suggested and distributed within groups. Dennis Ballinger
3 2014-05-06 Discussion on Topic "Challenge" and User Case 1. Hongfei Guo
4 2014-05-20 Discussion on Topic "Background" and User Case 2. Natalia Smeljanski
5 2014-06-03 Presentations on User Case 3 and User Case 5. ---
6 2014-06-17 Presentations on User Case 4 and User Case 6. Jane Lozano
7 2014-07-01 Discussion on Topic "Process Flow" and first draft. Tatyana Kovtun
8 2014-07-15 Final agreement on draft to be published. Trevor Mankus
9 2014-07-29 Post-steering review discussion. Natalia Smeljanski

Meeting Minutes

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