CDISC Certification – One Company’s Experience Christopher Ernenwein PHT Corporation as presented at DIA US 2009

1. CDISC Certification – One
Company’s Experience
Christopher Ernenwein
Sr. Software Engineer
PHT, Corp.

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3. Agenda
Rationale
Process
Examples of data
Examples of process
Document produced
Lessons learned
Q&A
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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
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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
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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
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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
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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
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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
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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
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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
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12. ODM
Example
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13. ODM
Clinical
Data
Example
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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
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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
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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
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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
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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
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19. Q&A
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