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Clinical Research Homepage

Training & Compliance

GCP TRAINING FOR CLINICAL RESEARCH STAFF AND INVESTIGATORS

Springfield Clinic's Clinical Research Department maintains a knowledge-based and skill-based training program to ensure Regulatory Compliance, SOP Compliance and Protocol Compliance for all clinical research conducted by the Clinic’s investigators.

CLINICAL RESEARCH STAFF TRAINING

Staff: Study Coordinators, Regulatory Coordinator, Recruitment Coordinator, Research Manager, Director of Research

  • Orientation training program conducted by Team Lead
  • Weekly informal staff meetings to advise of critical changes
  • Monthly formal staff meetings (Attendance of 70% of meetings required)
  • Protocol Specific Training
    • Lead Coordinator &/or backup attends Investigator’s Meeting
    • All members of Team attend initiation meetings
  • Periodic review of SOPs and training on any modifications
  • Annual web-based training module required
  • IATA hazardous shipping training required every two years
  • Beginning in 2007, all eligible coordinators will be required obtain SOCRA CCRP certification
INVESTIGATORS: Principal Investigators and Sub-Investigators
  • Web-based training certificate required during credentialing
  • Protocol specific training for Principal Investigator prior to initiation of patient recruitment
  • Review of Investigator performance by Research Committee through reports
    • Enrollment Report
    • Monitoring Report