- 1 Working Group Overview
- 2 Leadership Team
- 3 Current Projects
- 4 News
- 5 Working Group Meeting Minutes
- 6 Conference Records
- 7 Closed Projects
- 8 Legacy Projects/Information
- 9 FDA Disclaimer
- 10 Disclaimer for Others
Working Group Overview
|Mary Nilsson||Industry Co-lead and Steering Committee Liaison||Lilly||nilsson_mary_e (at) lilly.com|
|Hanming Tu||Project Manager||Frontage||htu (at) frontagelab.com|
|Mat Soukup||FDA Liaison||FDA||mat.soukup (at) fda.hhs.gov|
- [ Standard_Script_Index ] [Simple Index In Github] - Frond-end User Interface (Hanming Tu)
- Github: Script Repository
- P01 - SDA: Script discovery and acquisition (Rebeka M Revis; Looking for a co-lead)
- P02 - RCD: Repository content and delivery (Gustav Bernard; Andrew Miskell; FDA Liaison: Mat Soukup)
- P03 - RGI: Repository governance and infrastructure: (Hanming Tu and Mike Carniello)
- P07 - CPE: Communication, Promotion and Education (Jared Slain and Wendy Dobson)
- P08 - ADW: Analysis and Display White papers (Mary Nilsson)
- P09 - TDF: Test Data Factory (Peter Schaefer)
- Script Metadata for Sharing
- 02 May 2017: Mary and Hanming gave a webinar to ASA: [ASA presentation] and [Recording]
- February 2017: The Adverse Events White Paper was finalized. The final copy is in the PhUSE Deliverables Catalog
- 25 August 2016: Draft 2 of the Adverse Events white paper is available for review until 14 October 2016. See[white paper wiki page] for instructions on how to participate in the review.
- 11 May 2016: We renamed this working group from Development of Standard Scripts for Analysis and Programming to Standard Analyses and Code Sharing.
- 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
- 27 Aug 2015: All-hands meeting [slides]
- 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.
- 07 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].
- 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
- 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.
- 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.
- 18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: CSS conference
- 10 October 2013: The Central Tendency White Paper has been finalized!
- 26 June 2013: Hackathon_notes_20130626 are posted
- 01 May 2013: Individual Contributor License Agreement (Draft)
- FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
- The final draft of PhUSE Standard Scripts Update (Date Published: March 1, 2013)
- User Guide for Standard Script Repository has been drafted. (Date Published: February 28, 2013)
- The first Call for Scripts has been issued and a press release issued.
- GitHub has been chosen for our repository.
Working Group Meeting Minutes
|Year 2013||Year 2014||Year 2015||Year 2016||Year 2017||Year 2018|
- PhUSE CSS 2017 Agenda
- Annual Conference 2017
- Background and Vision - Mat Soukup
- Working Group Overview - Mary Nilsson/Hanming Tu
- Project Updates - All Project Co-leads
- Script Development - Gustav Bernard/Andrew Miskell
- JumpStart Scripts - Rebeka Revis
- Inter Active Display using Spoffire - Rebeka Revis
- ADW and Data Visualizations Joint Meeting - Mary Nilsson
- ADW and Collection Instructions Joint Meeting - Mary Nilsson
- Breakup and Wrap-up Sessions
- PhUSE SDE 2016
- PhUSE/CSS 2016 WG Agenda
- PhUSE/CSS 2016 Meeting Slides
- PhUSE/CSS 2016 Agenda
- PhUSE/CSS 2016 Motivation
- PhUSE/CSS 2016 Project Updates
- PhUSE/CSS 2016 Git and Github
- 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
Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.
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.