WG5 P02 Notes, CSS Annual Meeting 18-19 March, 2013
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Notes, CSS Annual Meeting 18-19 March, 2013
- Define the minimum standards by which a script/tool/program can be considered validated.
- Minimum standards by which a script/tool/program can be considered validated:
- Robust without red errors in companies production environment
- 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
- 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
- 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.