Difference between revisions of "WG5 Project 02"

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Revision as of 15:18, 30 May 2013


Project Team

Project Lead
Jack Averill / Lina Jørgensen
Project Members


Project Description

New Project Name
Define qualification steps and metadata for scripts in the repository
Old Project name 
Define validation steps for scripts in the repository
Description
For a script to be considered validated, there would be some required documentation, such as user guide and program specification. The program specification would detail the scenarios under which scripts should work. A validated script would have a validation plan, complete with test data and a completed report of the results of the validation testing. This project is to define the minimum standards by which a script/tool/program can be considered validated. In addition, it will address the necessary processes needed to validate scripts, and to ensure that validation status can remain in the open source repository.


Project Progress


Milestones

After the FDA meetinng to have the first validate script in production.

Agende for FDA meeting
18-19 MAR2013
  • 1. Define the minimum standards by which a script/tool/program can be considered validated.
  • 2. It also covers the process of moving a script to “production” and flag it, as validated.


1. Define the minimum standards by which a script/tool/program can be considered validated.

A script/program is validated when:

  • 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 Endusers

2. It also covers the process of moving a script to “production” and flag it, as validated.

  • Moving a script to “production”:
  • Use folder ./src for non validated scripts
  • Use folder ./valid for validated scrips.
  • Discuss by whom and how
Reports

File:FDA Scrips.ppt

Project Meetings

  • Conclusion after the FDA/PhUSE meeting:
  • No Companies will allow programmer/statisticians to download a validation script
  • and use it without validation according to the companies SOP
  • The check list will instead be a part of the User Guide: How to ad 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 DanBoisvert,05/30/2013