Difference between revisions of "WG5 Project 02"

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:* Terry Walsh

Revision as of 21:46, 31 March 2015

Project Team

Project Leads:
Dante Di Tommaso (dante.di_tommaso (at) roche.com)
Peter Schaefer (pschaefernet (at) yahoo.com)

Project Members:
New participants from the 2015 annual conference:

  • Austin Taylor
  • Dirk Spruck
  • Frank Senk
  • Gustav Bernard
  • Jeno Pizzaro
  • Mercy Navarro
  • Peter Glass
  • Rebeka Tabbey
  • Terry Walsh

Continuing participants:

  • Yingshan You (yyou (at) its.jnj.com)
  • Anders Vidstrup (avid (at) nnit.com)
  • Lina Jørgensen (liuj (at) novonordisk.com)

If you want to participate, please simply contact Dante or Peter, above.

Project Description

Name: Repository Content and Delivery

Description: This working group relies on distributed volunteers to review, develop, test and qualify Standard Scripts for general use. Volunteers should be able to easily find ways to contribute, either by improving our processes or working directly on the qualification of Standard Scripts. In 2014, we defined a process and associated roles for qualifying repository code. See File:Qualification of CSS scripts.xlsx in Project Documents, below.

Moving forward in 2015, we will exercise and refine this qualification process while delivering a "Central Tendencies" package based on the published CT white paper from P08 - Analysis and Display White papers.

Project Progress

Approach for 2015

  • Specify improvements to Repository metadata and interface
  • Specify improvements to Specifications for white paper targets, including how and where we document and publish
  • Revise the Qualification process

Notes from CSS annual meeting: 16-17 MAR2015

  1. Proceed with qualification process as proposed
  2. Exercise process on specific deliverable for 2015, the Central Tendencies package
  3. Use contributed code for ideas rather than trying to qualify contributed code
  4. Develop and deliver "Template programs with extras", as proposed in WG5 P02 Qualification Process for Standard Analyses

Notes from FDA meeting: 18-19 MAR2013

  1. Define the minimum standards by which a script/tool/program can be considered validated.
  2. Minimum standards by which a script/tool/program can be considered validated:
  • Robust without red errors in companies production environment
  • -or-
  • Robust and used in FDA scripts repository, and some kind of ranking, e.g. with stars : ******.
  • Open CDISC validator or Data Fit used to check input/output.
  • SDTM/ADaM used in input/output.
  • GPP in source.
  • Docmented or perhaps only documented in header.
  • User Guide.
  • Requirement specification.
  • Run according to Requirement specification.
  • Tested by validation plan, test program all Peer reviewed
  • Tested by End users
  1. Moving a script to "production" (fully qualified):
  • Use folder ./src for non validated scripts
  • Use folder ./valid for validated scrips.
  • Discuss by whom and how

Project Documents

Project Presentations & Posters

Project Meetings

Conclusion after the 2013 FDA/PhUSE meeting

  • Companies will not allow programmers/statisticians to use a "validated", external script
  • Without some validation according to the companies SOPs
  • The check list will instead be a part of the User Guide: How to add a script to Google Code.
  • Validation will be called "qualification".
  • The qualifications will be based on a rating of each script (Metadata)
  • Qualification will be a part of the Metadata subgroup, which Lina J. will join.
  • Only scripts developed directly to a White Paper should be Validated in the common sense of the word
  • A small paper about this change will be produced together with the Members that joined this group at the FDA meeting.

Last revised by DanteDT,03/31/2015