with OpenCDISC Validator

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What is

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OpenCDISC ValidatorOpen source projectFreely AvailableCommercial-qualityFacilitate compliance with CDISC standards

SDTMADaMODMLABSEND

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How does it work?

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Key CharacteristicsSeparates validation rules from application

logicAll validation rules and messages in a single

XML document, ODM ExtensionGives control over validation rules to the

userPower to specify a wide range of rulesFlexibility to support many formatsDifferent configurations for every study and

stage of clinical data lifecycle5

How does it help me with SDTM?Provided with 3 validation configurations

Janus v.1 WebSDM v2.6OpenCDISC (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

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Configurations

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Validation Rule TypesConditionMatchRegexLookupUniqueRequiredISO DatesNumeric

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Validation Reports

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Project StatusAlpha 2 Released Feb 2009

Supports 85% of Janus and WebSDM validation rules

Cross-dataset and DB lookup validationsAbility to validate against MedDRA and LOINC

Beta Release Planned for end of June 2009100% validation rule supportAbility to validate against controlled terminologyImproved error reporting

Production Release Nov 2009

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Growing the CommunityThanks to everyone who has contributedNot to late to join

User FeedbackDocumentationValidationDevelopment

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Questions/FeedbackWhat 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?

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Contact InformationMax KanevskyFounderOpenCDISC.orgmax@opencdisc.orgmkanevsky@pinnacle21.net215.858.1126

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