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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 

kevin.snyder@fda.hhs.gov

William Houser

william.houser@bms.com

Paula Rowley (PHUSE Project Assistant)paula@phuse.global 



Objectives and 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
Michael DeNieuLabcorp
Susan ButlerFDA
Wenxian WengBristol Myers Squibb



Project Members 

Organisation 
Elaine ThompsonFDA

Eli Miller

Atorus Research

Fred Mura

PDS Life Sciences

Hanming Tu

Frontage Laboratories

Jarad Slain

MPI Research

Kevin Cahill

EPL

Kevin Snyder

FDA
Michael RosentreterBayer
Raymond Deheer Charles River
Sabbir AhmedFDA



Utilised feedback

Status
colourBlue
titleCurrent Status
Q22021

Q3/42021

Presented SEND igR package at the PHUSE US Connect.

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



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