Site Initiation:
     • Institutional review board (IRB) approval
     • Research site selection and evaluation
     • Contract negotiations with the trial institution
     • Patient recruitment
     • Patient follow-up
     • Informed consent form (ICF) translation into vernacular languages.
     • Investigator’s meetings
     • Personnel training
     • Site setup and training for EDC

Site Monitoring:
     • Source data validation
     • Checking internal consistency of CRF data
     • Data Query Management
     • Issuing Data alerts to CDM
     • Reporting serious adverse events to the IRB/IEC
     • Monitoring of enrolment rate and patient eligibility criteria
     • Drug accountability
     • Trial-related documents archival and maintenance
     • Onsite monitoring and audits
     • Site closure

Project Management:
     • Research site liaison
     • Progress and status reports
     • Tracking CRFs and DCFs
     • Medical monitoring and reporting of serious adverse events
     • Onsite support and help desk for EDC