—Input in CRF design
—e-Platform setup (incl. ePRO/IWRS), testing & validation
—Annotated CRF
—Data Validation Plan (DVP)
—Data Management Plan (DMP)
—Data Cleaning Plan (DCP) & Programming
—Data exchange with external data sources
and systems (in/out)
—eCRF completion guidelines
—e-Platform and database hosting
—Data Cleaning Process
—Risk-based 1st line or 2nd line Database Monitoring
—Data exports
—AE/SAE reconciliation
—Quality control: data entry, programming of validation checks, entry of queries
—Data reconciliation across multiple sources and systems
—Database lock, transfer & archiving
—Data Management Report
