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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

Lauren White (PHUSE Project Coordinator)lauren@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

BMS

Bill Varady

Boehringer Ingelheim

Bob Friedman

Xybion

Dhamodharan Ravindiran

Industry

Drashtti Vasant

Bayer

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

CURRENT STATUSQ12021

  • Improved performance of the SEND Test Data Factory as well as improved realism of data generated, e.g. time-dependence for BW and FW
  • Generated initial version(s) of R package, sendigR, which facilitates the generation and searching of a historical control database from SEND datasets
  • Began work on R script that interprets CDISC conformance rules and checks SEND datasets against them
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

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