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.

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. 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.