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|
- P01: Look for existing scripts and store them in the repository (Adie Bonwick and Aiyu Li)
- P02: Qualification of scripts in the repository (Dante Di Tommaso; Lina Jørgensen through 2013)
- P03: Maintain and enhance platform (repository) for sharing scripts (Mike Carniello/Hanming Tu)
- Ongoing [ Standard_Script_Index ]
- 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)
- P07: Implement and further develop communication plan for standard scripts (Dirk Spruck)
- P08: Create white papers providing recommended display and analysis including Table, List and Figure shells (Mary Nilsson)
- P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
- Closed, any remaining tasks moved to Project 03
- 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.
- 09 Oct 2014: Draft 3 of the Outliers/Shifts white paper is available for review until 01 December 2014. This will likely be the draft sent for review.
- 09 Oct 2014: Version 1 of the Demographics/Disposition/Medications white paper has been finalized and available on www.phuse.eu (Publications section).
- 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.
- Google Code has been chosen for our repository.
Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.
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