Difference between revisions of "Standard Analyses & Code Sharing"

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= News =
 
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# 27 Aug 2015: All-hands meeting slides.
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# 27 Aug 2015: All-hands meeting [[http://www.phusewiki.org/wiki/images/5/5d/Standard_Script_All-Hands_meeting2015_v3.pdf 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 [[http://www.phusewiki.org/wiki/index.php?title=SS_P08_Adverse_Events_White_Paper white paper wiki page]] for instructions on how to participate in the review.   
 
#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 [[http://www.phusewiki.org/wiki/index.php?title=SS_P08_Adverse_Events_White_Paper white paper wiki page]] for instructions on how to participate in the review.   

Revision as of 12:58, 27 August 2015


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

Name Role Organization E-mail
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

Current Projects

  • [ Standard_Script_Index ] - Frond-end User Interface
  • 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. 27 Aug 2015: All-hands meeting [slides]
  1. 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.
  2. 09 Oct 2014: Draft 3 of the Outliers/Shifts white paper is available for review until 01 December 2014. This will likely be the last draft sent for review. See the [white paper wiki page] for instructions on how to particpate in the review.
  3. 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].
  4. 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
  5. 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.
  6. 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.
  7. 18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: CSS conference
  8. 10 October 2013: The Central Tendency White Paper has been finalized!
  9. 26 June 2013: Hackathon_notes_20130626 are posted
  10. 01 May 2013: Individual Contributor License Agreement (Draft)
  11. FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
  12. The final draft of PhUSE Standard Scripts Update (Date Published: March 1, 2013)
  13. User Guide for Standard Script Repository has been drafted. (Date Published: February 28, 2013)
  14. The first Call for Scripts has been issued and a press release issued.
  15. Google Code has been chosen for our repository.

Group Meetings

Standard Script Group Meeting Minutes
Year 2013 Year 2014 Year 2015
08Jan2013

16Jan2013
22Jan2013
30Jan2013
06Feb2013
13Feb2013
20Feb2013
27Feb2013
13Mar2013
19Mar2013 Platform breakout session
19Mar2013 White Paper Breakout Session
03Apr2013
17Apr2013
01May2013
15May2013
12Jun2013
26Jun2013
10Jul2013
24Jul2013
07Aug2013
21Aug2013 Co- and Project-Lead Meeting
28Aug2013 Co- and Project-Lead Meeting
04Sep2013
18Sep2013
02Oct2013
16Oct2013
30Oct2013
13Nov2013
04Dec2013
18Dec2013

08Jan2014
22Jan2014
05Feb2014
19Feb2014
07Mar2014
17Mar2014Phuse
07Apr2014
16Apr2014
30Apr2014
14May2014
28May2014
11Jun2014
23Jul2014
06Aug2014
03Sep2014
17Sep2014

21Jan2015
19Feb2015
17Mar2015 Phuse2015CSS
01Apr2015
29Apr2015
27May2015
15Jul2015
05Aug2015
19Aug2015


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.