eDataValidator

The eDataValidator (eDV) is a powerful and comprehensive validation tool for all clinical and nonclinical study submission datasets to the FDA or PMDA.

• Access the eDataValidator from the AWS Marketplace by clicking on this link.
  
  

eDataValidator capabilities include:

• A Validator for SDTM, ADaM, SEND and define.xml validating them against the following:
• FDA Validator Rules 1.3
• PMDA Rules for SDTM
• PMDA Rules for ADaM 1.0
• PMDA Rules for Define.xml
• CDISC Conformance rules 1.1 ( under development )
• PointCross Extended rules.




• Supports dataset as XPT, CSV, saas7bdat, CDISC DataSet Xml and Excel.
• EDV Server – Designed for a team to monitor study progression over time:
• Secure space to load and validate study that support SAML based single sign on for login.
• Version control of data and validation outputs.
• Quality control dashboard with interactive views for issue drill down and to determine if a reported issue should be reported in SDRG or if it warrants a corrective action.
• Review the validation status over time as you get ready for submission.




• EDV Desktop – Designed with a SDTM, ADaM and SEND data preparer in mind.
• Has the same engine used on the server product.
• Useful for iterative validation as data fixes are made.
• Ability for select specific rules in focus from the ruleset to quickly check if fixes made are really addressing the validation failures.
• Ability to automatically compare the current validation with a baseline report.
• Gives data preparer’s more confidence to commit their script and dataset changes to their master repository.




• CLI (command line interface) and Scripts for automatic and periodic validation of a collection of studies.
• Periodic updates with release notes.
• Access to PointCross Wiki page where we publish our roadmap and provide an issue management registry.