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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. - PowerPoint PPT Presentation
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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 [email protected]@pinnacle21.net215.858.1126
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