CDISC Certification V1

CDISC Certification – One Company’s Experience

Christopher ErnenweinSr. Software EngineerPHT, Corp.

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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.

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Agenda

RationaleProcessExamples of dataExamples of processDocument producedLessons learnedQ & A

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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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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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• 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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• 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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• 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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• 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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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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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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ODM Example

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ODM Clinical Data Example

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Data Generation and Testing Process Flow

XML Data from Server

XSL Parser

XSL Stylesheet

ODM File

ODM Conform

Parsing

ODM Conform

Output

Testing Error Correction

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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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ODM Certification PHT Study Works

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

ODM Certification Document

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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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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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Q & A

Technology

CDISC Certification V1