Nonclinical Script Assessment Project

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Welcome to the site for the "Nonclinical Script Assessment Project" group.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. We are part of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

Project Overview

Identified Need/Challenge

Analysis scripts for SEND data would be valuable tools. Can existing clinical scripts be used to help develop nonclinical scripts? What is the best process for prioritizing, developing, and releasing analysis scripts for SEND data?

Project Scope

To explore the development of analysis scripts based on SEND data.



1) Evaluate existing clinical scripts for nonclinical script development
2) Develop a process for prioritizing, developing, releasing and maintaining analysis scripts for SEND data
3) Review outputs from the SEND for Analysis and Histopathology Visualization groups to identify possible scripts for development
4) Create "work packages" for the high priority scripts in time for a 2017 March scriptathon.


March 2016 - March 2017

1) Learn processes used by the clinical scripts team
2) Publish the processes, if different from those used by the clinical scripts team
3) Publish status of project at PhUSE CSS March 2017


Upcoming milestone:


1) Group communication via email: every two weeks
2) Web conferences: every four weeks
3) PhUSE Wiki: ad hoc


  • End of Q2 2016 - Learn the activities and processes in use by the clinical script team and determine how to work with them and or adapt their processes
  • End of Q3 2016 - Establish processes for prioritizing, developing, releasing, and maintaining analysis scripts for SEND data
  • End of Q4 2016 - Create “work packages for the high priority scripts in time for a 2017 March scriptathon
  • End of Q1 2017 - Prepare poster describing achievements for PhUSE CSS 2017.

Participation Needs

The team was established at the PhUSE CSS March 2016.

Call for participation!

What is the commitment?

  • Time (minimum of 1 hour every 2-3 weeks for team meetings, up to 3 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • Wiki - creating/reviewing page content

If you would like to participate, please contact the co-leads for this group: or

Work Group Participants


  • Bill Houser, BMS
  • Kevin Snyder, FDA
  • Kevin Cahill, EPL
  • Bill Varady, Boehringer Ingelheim
  • Bob Dorsam, FDA
  • Bob Friedman, Xybion
  • Chris Eley, Pfizer
  • Anthony Fata, PDS
  • Fred Mura, PDS
  • Elaine Thompson, FDA
  • Stephen MacMannis, Pfizer

Conference Calls and Minutes

Our meetings are scheduled every other Thursday at 10am Eastern continuing from March 30, 2017

To join one of our regular meetings use this link:

  • Dial +1 (872) 240-3412
  • Access Code: 992-486-229

Meeting Minutes

April 1, 2016 Meeting Notes
April 29, 2016 Meeting Notes
May 12, 2016 Meeting Notes
May 26, 2016 Meeting Notes
June 9, 2016 Meeting Notes
June 23, 2016 Meeting Notes (meeting with vendors)
June 30, 2016 Meeting Notes
July 14, 2016 Meeting Notes
Aug 4, 2016 Meeting Notes
Aug 18, 2016 Meeting Notes
Sept 1, 2016 Meeting Notes
Sept 22, 2016 Meeting Notes
Oct 13, 2016 Meeting Notes
Oct 27, 2016 Meeting Notes
Nov 10, 2016 Meeting Notes
Dec 8, 2016 Meeting Notes
Jan 5, 2017 Meeting Notes
Jan 19, 2017 Meeting Notes
Feb 16, 2017 Meeting Notes
Mar 2, 2017 Meeting Notes
Mar 16, 2017 Meeting Notes
Mar 30, 2017 Meeting Notes
Apr 13, 2017 Meeting Notes
Apr 27, 2017 Meeting Notes
May 11, 2017 Meeting Notes
May 25, 2017 Meeting Notes
Jun 8, 2017 Meeting Notes
Jun 22, 2017 Meeting Notes
Jul 6, 2017 Meeting Notes
Jul 20, 2017 Meeting Notes
Aug 3, 2017 Meeting Notes
Aug 17, 2017 Meeting Notes
Aug 31, 2017 Meeting Notes
Sep 28, 2017 Meeting Notes
Oct 12, 2017 Meeting Notes
Oct 26, 2017 Meeting Notes
Nov 9, 2017 Meeting Notes
Dec 7, 2017 Meeting Notes
Dec 21, 2017 Meeting Notes
Jan 4, 2018 Meeting Notes
Jan 18, 2018 Meeting Notes

Working Pages

Nonclinical Scripts - Challenges and Solution Ideas
List of Scripts

Reference Material

Getting GitHub script repository access for contributors

Coding Standards:

PhUSE group focused on Good Programming Practices:

Learning R for SAS programmers

  2. SASxport Users Guide -
  3. R for SAS programmers: It’s different, but friendly -

More R Resources

  1. Cheat Sheets for R Concepts and Packages -
  2. Using R for Data Analysis and Graphics -