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Project Scope

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 prioritising, developing and releasing analysis scripts for SEND data?



Project LeadsEmail
Kevin Snyder (FDA) 

kevin.snyder@fda.hhs.gov

William Houser (Bristol Myers Squibb)

william.houser@bms.com

Katie Warren (PHUSE Project Assistant)katie@phuse.global



Objectives & DeliverablesTimelines
Create software that generates SEND data useful for demonstrating data visualisation tools, testing software that receives data from the standard, especially as standards are approaching finalisation. 2021
Create large enough data sets for testing visualisation for data loading tools for capacity testing 2021
Create example code to show: R script creation of XPT files, R script reading of the standard, R script reading of CT files. 2021 



Project Members 

Organisation 
Anthony FataSNBL

Atul Mishra

Pfizer

Bill Houser

Bristol Myers Squibb

Bill Varady

Boehringer Ingelheim

Bob Friedman

Xybion

Dhamodharan Ravindiran

Industry

Drashtti Vasant

Bayer
Elaine Thompson FDA
Eli MillerAtorus Research
Fred MuraPDS Life Sciences



Project Members 

Organisation 

Hanming Tu

Frontage Laboratories

Jarad Slain

MPI Research

Kevin Cahill

EPL

Kevin Snyder

FDA
Michael DeNieu Labcorp
Michael RosentreterBayer
Raymond Deheer Charles River
Sabbir AhmedFDA
Susan ButlerFDA

Sweta Khare

Xybion
Wenxian WengBristol Myers Squibb



Status
colourBlue
titleCurrent Status
Q3/42021

  • Presented SEND igR package at the PHUSE US Connect.
  • Utilised feedback from validator results to improve the quality of generated SEND datasets. 



Other

Getting GitHub script repository access for Contributors

  1. Create account on GitHub site https://github.com/
  2. Send Hanming Tu (htu@frontagelab.com) your GitHub ID asking to be a contributor.
  3. Hanming will send an invitation that will come as an email from "GitHub"
  4. If you don't see the invitation link in your email, you can accept the invitation from https://github.com/orgs/phuse-org/invitation
  5. You can download/clone a whole repository to your computer if you have a client for the repository. You can get either TortoiseSVN (https://www.wikihow.com/Install-and-TortoiseSVN-and-Make-Your-First-Repository-Change) or GitHub desktop (https://desktop.github.com/). See the useful links at https://github.com/phuse-org/phuse-scripts/wiki/Read-Me-First-(Google-Code).
  6. Read other getting-started information here: https://github.com/phuse-org/phuse-scripts/wiki/Read-Me-First-%28Google-Code%29
  7. To see a list of contributed scripts
    1. get into GitHub and select the tab for the Wiki
    2. Look at the list on the right side and open the link for Simple Index
PHUSE group focused on Good Programming Practice Guidance
Safety Pharmacology Pilot
PHUSE SEND Data Factory Design V2
Converter tools between xpt and csv

Group SEND