Module 12 2019

Data Input/Output Front end: Templated CRF Design

● Information captured during most if not all studies (Demographics, Med History, Phys. Exam, Vitals, etc.) ● 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 ● Submission Ready eCRF ● CDISC Compliant Datasets

The Organisation for Professionals in Regulatory Affairs