Pre-study activities :
Study feasibility
Site qualification /Investigator selection
Execute and oversee Vendor agreements
Execute and oversee Investigator agreements
Patient recruitment & retention plans
Study initiation phase :
Facilitating investigator meeting
GCP training to site staff
IEC/IRB submission and approvals
CTRI registration
Protocol training
Safety management training
Preparation and implementation of study specific monitoring plans
Conduct of study initiation visits (SIV)
Perform First patient first visit (FPFV)
Study conduct phase :
Risk based monitoring/Central monitoring
Manage adverse event reporting and document protocol
deviations/violations
Site coordination, Clinical trial supplies and management
Oversee Site performance and compliance
Source data verification (SDV ) and quality checks at sites
Site readiness for Audits & Regulatory Inspections
Study closeout phase :
Perform Last patient last visit (LPLV)
IP accountability
Notification to IRB/IEC
Document archival
Site closeout
Database lock & archive