WG5 DDMONYYYY

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Welcome

Mission - Original

This working group will identify potential standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set. This will be an interactive session using online wiki to create and add input that can be shared openly between industry and regulatory.

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Leadership: Co-Leads

Mary Nilsson Eli Lilly mnilsson@lilly.com
Sally Cassells Next Step sally.cassells@gmail.com
Hanming Tu Octagon Research HTu@OCTAGONRESEARCH.com
Kevin Kane Phastar kevink@phastar.co.uk
Joy Li FDA - CDER Joy.Li@fda.hhs.gov
Mat Soukup FDA - CDER mat.soukup@fda.hhs.gov
Mark Walderhaug FDA - CBER Mark.Walderhaug@fda.hhs.gov

Steering Committee Liaison: Scott Getzin sgetzin@lilly.com

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Conference Calls and Minutes

WG5 11JAN2012
WG5 22FEB2012
WG5 14MAR2012
WG5 DDMONYYYY(template)


Approach

Charter

WG5 Charter

Agenda

Day 1 (Monday)

1:00 - 2:00 Full WG5 Introductions, goals and objectives (Full Group) 60 minutes

WG Charter Overview Sally
Collaboration: Challenges and Opportunities for developing Analysis Scripts Mat
Demonstration of CTSpedia for Safety Graphics Mat
Questions and Answers All

2:00 - 4:30 Subgroup Activities

Subgroup 1 What scripts do we want/need? (Mary, Mark)
Subgroup 1 Creation and validation of scripts (Kevin, Joy)
Subgroup 1 Platform for script management (Sally, Hamming, Mat)

Day 2 (Tuesday)

8:30 - 11:00 Subgroup Activities (Continued)

11:00 - 12:00 Full WG5

Prepare WG5 summary report

1:00 - 2:30 FDA/PhUSE Wrap up Session

Present WG 5 report

3:00 - 4:00 Conference Wrap Up


Example Scripts: Current and Future State

Script Example - Posted: March 14, 2012:

Example Overview Presentation

Current State Example Files

Future State Example Files

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--- Last revision by Scassells,03/15/2012