The FDA Study Data Validator is an enterprise system providing visibility of data compliance across the DHA, ensuring data integrity of the clinical product lifecycle. The FDA SDV provides a study data validation capability compliant with the Clinical Data Interchange Standards Consortium. The CDISC is a standards development organization which provides standards and best practices for medical research data linked to health care.
The FDA SDV allows the Office of Regulated Activities to validate the clinical and non-clinical datasets for electronic submission to the FDA. The system is vital to accelerate the process of submitting regulatory packages to the FDA for investigational product applications.
Features
Data Validation:
- Comply with CDISC standards and regulatory requirements
- Monitor data quality improvement over time
- View and track changes across historical validations
- View changes from the last validation
- Metadata driven and configurable
- Data Fitness Score
- Export Validation Reports
- Submission Checklist
- Validate SDTM, ADaM, SEND, BIMO, and Define.xml
Issue Management:
- Delegate and fix issues across decentralized teams and sites
- View a breakdown of issues by impact, status, and source
- Issue source tags to help categorize potential sources of the problem
- Gain real-time feedback on group efforts
- Projected score indicates your potential data fitness score
- Comment on issues, reuse your company-approved explanations, and share custom Fix Tips as advice for your peers
- View, sort, filter, and tag data issues intuitively, with options for bulk actions and dual screen view
- Auto-store reports and switch and/or compare easily to view new, resolved, or updated issues
- Review impact to gauge the likelihood of the issue impeding global regulatory reviews
DEFINE-XML Designer:
- Create Define.xml v20 or 21 for SDTM, ADaM, SEND, and BIMO
- Automate 80% of Define.xml using metadata extracted from validated datasets
- Extract page numbers from annotated CRFs to populate Origin
- Merge new cuts of data
- Generate Define.pdf
- Validate Define.xml content in real-time
Training & Demos:
- A variety of training options and demos are available for FDA SDV.
- If you would like to schedule a demo or training, or have any questions, please contact us.