Module 12 Presentations

Data Input/Output Front end: Templated CRF Design • Information captured during most, if not all, studies • (Demographics, Med History, Phys. Exam, Vitals, etc.)

• Submission-ready eCRFs • Time savings of WEEKS ! Middle: Data cleaning/reports • Real-time querying • Decision making • Preliminary report/table output Back end: Regulatory Deliverables for countries that require them • CDISC Compliant Datasets

The Organisation for Professionals in Regulatory Affairs