WG5 P02 Notes, CSS Annual Meeting 18-19 March, 2013

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Notes, CSS Annual Meeting 18-19 March, 2013

  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

Conclusion after the 2013 FDA/PhUSE meeting

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