Difference between revisions of "WG5 Project 02"

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* [[File:WG5_P02_Proposal_-_2014.pptx]] for Qualification of scripts
* [[File:WG5_P02_Proposal_-_2014.pptx]] for Qualification of scripts
* [[File:FDA_Scrips.ppt]] from 2013
* [[File:FDA_Scrips.ppt]] from 2013
== Project Presentations & Posters ==
== Project Presentations & Posters ==
* [[File:ScriptRepo+Qual-Abstract_PhUSECSS_2015.pptx]] Poster for Script Repository and Qualification Process, PhUSE CSS 2015 annual conference
* [[File:ScriptRepo+Qual-Abstract_PhUSECSS_2015.pptx]] Poster for Script Repository and Qualification Process, PhUSE CSS 2015 annual conference
== Project Meetings ==
== Project Meetings ==

Revision as of 02:59, 2 March 2015

Project Team

Project Members:
Dante Di Tommaso (dante.di_tommaso (at) roche.com)
Yingshan You (yyou (at) its.jnj.com)
(through 2013: Lina Jørgensen)

Project Description

Name: Qualification of scripts in the repository

Description: This working group relies on distributed volunteers to review, 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. This project will define roles, criteria and workflows for reviewing, developing, testing and ultimately qualifying scripts in the Standard Scripts repository for public use. This project will also define the metadata and mechanism to clearly communicate the state of these scripts to contributors as well as end users.

Project Progress


  • Define states along the qualification workflow
  • Define roles, responsibilities and criteria associated with each state and state transition
  • Propose resulting workflows to Standard Scripts working group

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,03/2/2015