Standard Analyses & Code Sharing
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.
|Mary Nilsson||Industry Co-lead and Steering Committee Liaison||Lilly||nilsson_mary_e (at) lilly.com|
|Hanming Tu||Project Manager||Accenture||hanming.h.tu (at) accenture.com|
|Steve Wilson||FDA Liaison||FDA||Stephen.Wilson (at) fda.hhs.gov|
|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 (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)
- 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
- 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.
PhUSE/CSS 2016 WG Agenda
- Conference Schedule for Standard Script Working Group
- 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
Detailed plan for the evening:
- Welcome to CSS 2016: Steve Wilson (10 min)
- CSS Logistics: Chris or Scott (10 min)
- Working Group Overviews (10 min each)
- 6:15-7 pm: We will direct attendees to each of the defined rooms for each working group. This 45 minutes is very informal and you are not expected to plan anything. It’s a chance to meet and greet, answer questions, and catch up with people
- 7 pm – close down (Semantics workshop begins at 7:30)
- 3/14/2016 Monday
- Monday 11:00 am - 12 pm - the whole group
- Background and Motivation (Steve/Mat)
- Overview of the WG (Mary)
- Updates from three focus areas
- Whitepaper Update (Mary)
- Repository Update (Mike/Dante/Adie)
- Communication (Dirk)
- Monday 1:00 - 4:30 pm - Breakout sessions
- 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
- 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
|Year 2013||Year 2014||Year 2015||Year 2016|
Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.
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