WG1 Top 20 27-Aug-2012

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Attended

Amy Malla X Anne Russotto X Mitra Rocca
Mike Molter X Nancy Tanner X Max Kanevsky
Akira Soma Sergiy Sirichenko X
Carina Soldner Hany Aboutaleb X
Carol Vaughn Sam Ogunbo
Anthony Chow X Susie McCune
Tatiana Sotingco Armando Oliva Chuck Cooper X

Discussion Topics

  • Next Steps

Action Items

  • Add date of external communication to Wiki – completed
  • Review the minutes and add comments, pro/cons to the potential resolutions listed. - ALL

General Process

General Steps:

  1. Investigate intent of validation rule and what causes it to trigger
  2. Investigate what is in the IG that informs industry practices
  3. Assign to a bucket (could be multiple)
  • IG Clarification/update
  • Rule change or language clarification
  • Guideline from Agency
4. Interface group with CDISC, OpenCDISC, FDA, CAB Validation project for resolution –the Wiki will have a date of communication to external organization added and we will work within Wiki
  • Create Communication Template to document issues, investigation and next steps – no longer needed
  • Create tracking spreadsheet (for example Item/Status/Category/Priority) – no longer needed