Revision as of 10:41, 11 February 2016

Working Group Overview

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.

Leadership Team

Current Projects

• [ Standard_Script_Index ] [Simple Index In Github] - Frond-end User Interface (Hanming Tu)
• P01 - SDA: Script discovery and acquisition (Adrienne Bonwick and Aiyu Li)
• P02 - RCD: Repository content and delivery (Dante Di Tommaso and Peter Schaefer)
  • Central tendency package: target – March 13, 2016
• P03 - RGI: Repository governance and infrastructure: (Mike Carniello and Chris Butler)
• P07 - CPE: Communication, Promotion and Education (Dirk Spruck)
• P08 - ADW: Analysis and Display White papers (Mary Nilsson)

Closed Projects

• P04: Legal ownership and issues in open source repository (Sally Cassells)
  • Task completed, creating a summary is planned
• P05: Create templates and metadata for documenting scripts and coding practices (Jean-Marc Ferran and Eric Sun)
  • Closed, remaining tasks are folded into RGI project.
• P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
  • Closed, any remaining tasks moved to Project 03

News

1. 10 Sep 2015: Final white paper version 1.0 of white paper on Outliers or Shifts from Normal to Abnormal: File:CS WhitePaper OutliersShifts v1.0.pdf
2. 27 Aug 2015: All-hands meeting [slides]
3. 09 Oct 2014: Draft 1 of the Adverse Events white paper is available for review until 01 December 2014. This review is a partial draft intended to get initial feedback on the proposed tables and figures. See the [white paper wiki page] for instructions on how to participate in the review.
4. 09 Oct 2014: Version 1 of the Demographics/Disposition/Medications white paper has been finalized and available on www.phuse.eu (Publications section). The white paper is also available from the [CSS Catalog of Deliverables].
5. 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
6. 26 June 2014: Draft White Paper Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Submission Documents is available for review until 8 August 2014.
7. 25 March 2014: Version 1 of PK white paper is available Analyses and Displays Associated to Non-Compartmental Pharmacokinetics – with a Focus on Clinical Trials.
8. 18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: CSS conference
9. 10 October 2013: The Central Tendency White Paper has been finalized!
10. 26 June 2013: Hackathon_notes_20130626 are posted
11. 01 May 2013: Individual Contributor License Agreement (Draft)
12. FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
13. The final draft of PhUSE Standard Scripts Update (Date Published: March 1, 2013)
14. User Guide for Standard Script Repository has been drafted. (Date Published: February 28, 2013)
15. The first Call for Scripts has been issued and a press release issued.
16. GitHub has been chosen for our repository.

Group Meetings

PhUSE/CSS 2016 WG Agenda

Conference Date and Location

March 13~15, 2016 Silver Spring Civic Center Silver Spring, Maryland, USA

3/13/2016 Sunday Night

Working Group Overview (5:00 - 7:00 pm)

• 5:15~6:15 Working Group Introduction
  • 10 minute presentation (Mary/Hanming)
  • Need to prepare 5~8 slides

3/14/2016 Monday

• Monday 11:00 am - 12 pm - the whole group
  • Background and Motivation (Steve/Mat)
  • Mary: Overview of the WG
  • Updates from three focus areas
    • Whitepaper Update (Mary)
    • Repository Update (Mike/Dante/Adie)
    • Communication (Dirk)

• Monday 1:00 - 4:30 pm - Breakout sessions
  • White papers
    • Adverse event displays
    • Hepatotoxicity displays
    • Displays for TQT Studies
  • Repository:
    • Git overview and philosophy (Mike)
    • Plan for qualification process and content creation (Dante/Peter)
    • Git Exercises/examples on github and phuse-script (Dante/Peter/Jeno)
    • Create and publish Index page/Wish list(Hanming)

• Monday 6:00 pm ~ 7:30 pm - Workshop
  • Workshop to edit real scripts live
  • Dante/Jeno/Peter: workshop using git to edit real scripts, make new ones, whatever (attendees need computer to log in, etc.)
  • Attendees do the work

3/15/2016 Tuesday

• Tuesday 8:30 am -12:00 pm
  • 8:30 – 9:00 am: Group Meet
  • 9:00 – 10:00 am: Meet with Results Analysis Metadata WG
  • 10:00 – 10:15: Coffee Break
  • 10:15 – 12:00 breakout
    • Whitepapers
      • Adverse event displays
      • Hepatotoxicity displays
      • Displays for TQT Studies
    • Repository:
      • Project conventions/development guidelines: Dante
      • File name convention and folder structure: Mike/Peter
      • YML and Metadata: Hanming

• Tuesday 1:00 pm - 2:00 pm - the whole Group
  • FDA scripts: what from here?
  • Lookout for the future
  • Wrap up together: the whole WG

Working Group Meeting Minutes

Legacy Projects/Information

Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.

FDA Disclaimer

FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.

Disclaimer for Others

Documents and comments provided as part of the PhUSE CSS Working Group efforts represent the individual's best judgment. They do not necessarily reflect the view and/or policies of their company or institution, the employers of the individuals involved or any of their staff.

Note: Individuals participating in PhUSE CSS Working Group discussions on the wiki are responsible for determining whether this disclaimer is sufficient for complying with any relevant procedures from their company or institution.