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Validating SDTM

Validating SDTM. with OpenCDISC Validator. What is. OpenCDISC Validator. Open source project Freely Available Commercial-quality Facilitate compliance with CDISC standards SDTM ADaM ODM LAB SEND. How does it work?. Key Characteristics.

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Validating SDTM

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  1. Validating SDTM with OpenCDISC Validator

  2. What is

  3. OpenCDISC Validator • Open source project • Freely Available • Commercial-quality • Facilitate compliance with CDISC standards • SDTM • ADaM • ODM • LAB • SEND

  4. How does it work?

  5. Key Characteristics • Separates validation rules from application logic • All validation rules and messages in a single XML document, ODM Extension • Gives control over validation rules to the user • Power to specify a wide range of rules • Flexibility to support many formats • Different configurations for every study and stage of clinical data lifecycle

  6. How does it help me with SDTM? • Provided with 3 validation configurations • Janus v.1 • WebSDM v2.6 • OpenCDISC (hybrid + community experience) • Just download, install, select validation configuration, and run • What about additional checks or SDTM+ datasets? • Just modify the XML by following directions on our site or ask our forum

  7. Configurations

  8. Validation Rule Types • Condition • Match • Regex • Lookup • Unique • Required • ISO Dates • Numeric

  9. Validation Reports

  10. Project Status • Alpha 2 Released Feb 2009 • Supports 85% of Janus and WebSDM validation rules • Cross-dataset and DB lookup validations • Ability to validate against MedDRA and LOINC • Beta Release Planned for end of June 2009 • 100% validation rule support • Ability to validate against controlled terminology • Improved error reporting • Production Release Nov 2009

  11. Growing the Community • Thanks to everyone who has contributed • Not to late to join • User Feedback • Documentation • Validation • Development

  12. Questions/Feedback • What additional validation checks are needed that are currently not documented by Janus and WebSDM? • At what point do you perform validation? • Validator currently handles xpt and flat files, do you have a need for other formats? XML? Oracle Views? • What other tools do you need?

  13. Contact Information Max Kanevsky Founder OpenCDISC.org max@opencdisc.org mkanevsky@pinnacle21.net 215.858.1126

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