Research

1

• Research

January 25, 2013 GCP Refresher Course Credit
3.0 hours Certificate of Completion Presented
to Sandhya Patel
V.P Research Dr. Bruce Pollock
Research Training Coordinator
2

• Training included a review of the following
  sections
• GCP Overview
• The Principles of ICH GCP
• Investigators Responsibilities
• Qualifications and Agreements
• Adequate Resources
• Medical Care of the Participants
• Communication with the REB
• Compliance with the Protocol
• Investigational Product
• Randomization and Unbinding
• Informed Consent of the Research Participant
• Records and Reports
• Progress Reporting
• Safety Reporting
• Premature Termination or Suspension of Study
• Final Report
• Sponsor Responsibilities overview
• Additional Guidance for Research Studies