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.