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Regulatory Knowledge & Support

Safety Monitoring Services & Resources

Achieving Participant Safety

  • Assistance with data safety monitoring plans
  • Development of Data and Safety Monitoring plans (DSMP) – guidance in formulating and writing a DSMP
  • Evaluation of DSM plans
  • Reporting requirements for study
  • Specific plans for monitoring events

Data Safety Monitoring Plan

Clinical Research for Adults

Pediatric Clinical Research

Event Reporting

Oversight of DSM plans

  • Children's Hospital Colorado CTRC Study Monitoring Committees
    • Cooperative Pediatric DSMB Policy
  • University of Colorado Hospital CTRC Study Monitoring Committee
  • University of Colorado Boulder CTRC
  • National Jewish Health CTRC

Oversight Policy


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