Contract Monitoring

• Finalizing the protocol
• Finalizing the feasibility template.
• Finalizing the ICF template in English
• Finalizing the central Pharmacy activity
• Identifying the following vendors.
  • Translators
  • Courier(Logistics)
  • Data management
  • Central lab
• Identifying and finalizing the potential sites.
• Conducting feasibility
• Site qualification visits
• Regulatory submission.
• Obtaining regulatory approval.
• Site initiation
• Recruitment at the sites
• Interim monitoring visits2-3
• Quality check visits 1-2
• Site close out
• Archival of documents
• Data analysis.
• Final report.