OpenCDISC Validator
OpenCDISC Validator is a collaborative project to develop an open source, freely available, and commercial-quality tool for ensuring clinical data compliance with CDISC standards, including SDTM, ADaM, SEND, Define.xml, and others. The Validator’s key strength is its architecture that separates validation rules from application logic. The driver behind this design decision was to provide users the ability to keep up with evolving standards, sans the need to update and re-validate application logic. The validation rules are defined using XML-based validation framework with power to specify a wide range of rules and flexibility to support near-SDTM, SDTM+, and even custom datasets.
Validator's Key Features
- Metadata driven and configurable
- Validation rules and messages stored in XML
- Facilitates compliance with all CDISC models
- Supports SDTM v3.1.2 and v3.1.1
- Checks against SDTM specification, controlled terminology, and Define.xml
- Configurable to handle SDTM+ and near-SDTM datasets
- Companies can create own standard configurations and share with partners
- Detailed reporting in Excel, CSV, and HTML
- Requires no installation, just unzip and use
- Compact and portable, will even run off a USB flash drive
- Deploy it on a server or hosted environment to share company-wide
- Easy to integrate with existing systems and processes
- Built 100% open source, 100% Java
- Can run in a validated environment
- Commercial support available
Supporters
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