Group 1 – Develop Guidelines for Validation Rule Developers (Mitra)

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Develop Guidelines for Validation Rule Developers (Mitra) When: Monday, March 19th
Place: Silver Spring Civic Center | Sliver Spring, Maryland, USA
Facilitator: Mitra Rocca

Name Organization
Mitra Rocca FDA/CDER/OTS (FDA Co-Lead)
Hany Aboutaleb Biogen Idec (Industry Co-lead)
Max Kanevsky OpenCDISC (Industry Co-lead)
Lisa Lyons Johnson & Johnson
Ryan Burns Rho
Frederik Malfait IMOS Consulting / Roche
Mike Molter D-WISE Technologies
Gerlind Ruhnke Merck Serono
Bill Brandow UCB
Min Chen Vertex Pharmaceuticals
Xiaojun Jie FDA/CDER/OTS
Sergey Sirichenko Pinnacle 21

General discussion


  • Discuss key validation concepts
o Standards Compliance vs. Data Quality
o Compliant vs. Useful
  • Review existing approaches and common practices
o Summary from various development teams (OpenCDISC, HL7, CAB Validation Project, and ADaM Validation sub-group)
o What guidelines are being followed by each team?
o How does each team gathers metrics and evaluates rule effectiveness?
  • Discuss and propose guidelines for
o Rule numbering
o Messages and Descriptions
o Categorization
o Severity

• Evaluate specific examples

o Review common rules from SDTM, Define.xml, and ADaM
o How can they be improved?

• Practice defining new rules

o Try to create a few new checks for SDTM Amendment 1

Summarize group findings

  • Rule Numbering
o Needs to be unique
o No specific requirements around rule numbering
o We need to have more discussions around rule numbering
  • Description
• Correct scenario
o Not programming language
o Concise
o Complete
o Consistent
• Main Sentence when?
o Element name Should/SHALL
o Variable Label [Variable Name] SHOULD/SHALL be something, Condition (when or IF something)
  • Message
• Simple statement regarding what is wrong
o Consistent approach to the message, e.g.
o Invalid
o Missing
o Inconsistent
• Report to possibly specify values

Group Agenda

Group Discussion

Group Findings

Completed Project

Back to Working Group 1:Data Validation and Quality Assessment Homepage

Last revision by Mitrarocca,04/10/2013