CDISC Certification V1


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CDISC Certification – One Company’s Experience
Christopher Ernenwein
PHT Corporation

as presented at DIA US 2009

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CDISC Certification V1

  1. 1. CDISC Certification – One Company’s Experience Christopher Ernenwein Sr. Software Engineer PHT, Corp.
  2. 2. Disclaimer • The views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to Drug Information Association, Inc. (“DIA”), its directors, officers, employees, volunteers, members, chapters, councils, Special Interest Area Communities or affiliates, or any organization with which the presenter is employed or affiliated. • These PowerPoint slides are the intellectual property of the individual presenter and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. Drug Information Association, DIA and DIA logo are registered trademarks or trademarks of Drug Information Association Inc. All other trademarks are the property of their respective owners. 2
  3. 3. Agenda Rationale Process Examples of data Examples of process Document produced Lessons learned Q&A 3
  4. 4. Rationale for CDISC Certification • 3rd party certification strengthens CDISC compliance • Leverage existing XML infrastructure, CDISC compatibility and previous experience using ODM • Increase ODM adoption in industry through greater use of ODM • Support customer needs for ePRO EDC integration 4
  5. 5. CDISC ODM Certification Process • Select ODM certification type • ePRO data most commonly exported into sponsor repositories or other eClinical systems – Metadata export – Clinical data export 5
  6. 6. CDISC ODM Certification Process • Transactional files chosen as it includes edits and audit trail of eSource data • Worked with ODM 1.2.1 • Communicate with ODM Certifier to agree on timing of on-site visit and certification steps 6
  7. 7. CDISC ODM Certification Process • Identified files from three previous CDISC integration projects • Integration of all ePRO data into EDC System for sites to view diary forms in one system – transactional ODM used for nightly uploads 7
  8. 8. CDISC ODM Certification Process • Integration of key diary items into a third party portal for sponsors, transactional ODM used for biweekly uploads • Integration of one diary form into EDC System for sites, transactional ODM used for nightly loads 8
  9. 9. CDISC ODM Certification Process • Files scrubbed and sent to certifier to be run through ODM Conformer tool to assess compliance • Discrepancies identified, feedback sent back to technical team • The XSL Style sheet updated to resolve issues • Final style sheet written in less than 600 lines as system’s native XML similar to ODM 9
  10. 10. CDISC ODM Certification Process Site Visit by Certifier – Review of System Architecture – Review of XML ODM Import, Export Tools – Review of ODM files generated – Discussions with technical team about systems utilization of ODM • Final Files sent back to certifier after site visit with issues fixed • Show Final results 10
  11. 11. About the Conformer tool • Conformer Output: – Syntactic Errors • XML is well formed, structurally accurate • Data types specified as integers are integers – Semantic Errors - Conforms to the schema • Referential integrity – Any data references exist • Reverse Referential integrity: All code list definitions in the metadata are utilized 11
  12. 12. ODM Example 12
  13. 13. ODM Clinical Data Example 13
  14. 14. Data Generation and Testing Process Flow XML Data from Server Parsing XSL Parser ODM File Error Correction ODM Testing ODM XSL Conform Conform Stylesheet Output 14
  15. 15. Lessons Learned • ODM Certification process really exists • Process not onerous if system already designed using XML • Increased technical working knowledge of CDISC Standards • Certification should simplify process of using ODM for future integration projects 15
  16. 16. ODM ODM Certification Certification PHT Study Works Document Document Ref: P0162_REPORT Prepared by: D Iberson-Hurst Date: 27th May 2008 Issue: 0.1 58 Third Avenue Teignmouth Devon, TQ14 9DP United Kingdom © Assero Limited, 2008 16
  17. 17. Positives • Led to more customer business • Integration demo for DIA • A lot of optional elements / attributes • Brought CDSIC into the light in the company 17
  18. 18. Negatives • Decision about transactional versus (upsert) - not archive (archive did not fit our model) • Tool was changing during the process – moving target • Only validate format but not accuracy • Too many optional elements / attributes 18
  19. 19. Q&A 19