WG5 Project 02

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Revision as of 12:49, 21 April 2015 by DanteDT (talk | contribs) (Project Meetings)
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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
  • Anders Vidstrup
  • Lina Jørgensen


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:

  • folder WPCT contains template programs for White Paper Central Tendencies
  • folder utilities contains SAS macros that the template programs require
  • folder qualification contains test scripts that document the qualification of each component in WPCT and utilities
  • Notes about qualification:
  • 2014 proposal was to create a File:Qualification of CSS scripts.xlsx for each component to explain the qualification process and document tests and checks, as implemented for certification and confirmation stages
  • This now seems burdensome without real gain in accessibility or transparency
  • So we are now considering a simpler approach that remains similar in spirit: simply documenting tests and checks in scripts in the qualification folder, above.


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: Agenda & Minutes

2015 Agendas & Minutes

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,04/21/2015