1. with OpenCDISC Validator 1

2. What is 2

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

4. How does it work? 4

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 5

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 6

7. Configurations 7

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

9. Validation Reports 9

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 10

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

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? 12

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