Site Monitoring

CCRB offers monitoring service for clinical trials, adverse event and serious adverse event. Site monitoring is conducted to ensure protocol and regulatory compliance and timely submission of high-quality data to ensure facilities and staffs at the investigational site continue to be acceptable for the conduct of the study.
Monitoring activities consist of:

  • Review of facilities and equipment
  • Verification of study site documentation
    • Investigator’s Study File
    • Ethics Committee Documentation
    • Informed Consent Documentation
    • Regulatory Agency (SAE) Documentation
    • Sponsor / Monitor Documentation
    • Study Drug Documentation
    • Laboratory Documentation
    • Facility and Equipment Documentation
  • Verification of study subjects documentation
    • Informed consent
    • Subject Eligibility
    • Case report form
    • Source document
    • Monitoring of enrollment rate
    • Drug accountability
    • Administrative tasks