CRF Design (CDISC-CDASH)
Data Management Plan (DMP)
Design and programming of electronic CRF (eCRF)
System Validation Plan (SVP)
eCRF Completion Guidelines (eCCG)
Data Validation Plan (DVP): User Acceptance Tests (UAT), design and validation of Edit Checks and Listings, eCRF Dynamics
Transfer and Validation of external data (Lab, ECG, images, pK data, ePRO), Data Transfer Agreement / Data Transfer Specifications (DTA/DTS)
Data Cleaning: Discrepancy Management, follow-up, review and closure of Queries, manual review of listings -designed as per DVP
DM Training to Site personnel
Dictionaries: medical terms / medications: MedDRA, WHO-Drug
Safety Data Management and Safety Reconciliation (Adverse Events)
Protocol Deviations
Database Lock
Data Review Plan
Data Cleaning Plan
Risk Based Quality Management (RBQM)
