Deviations: What are they? Do you need to report? 2015

Topics

• Department of Health and Human Services (DHHS) guidance
• ICH guidelines and Good Clinical Practice (GCP)
• Types of deviations
• Food and Drug Administration guidance
• Review of institutional deviation policies and guidance documents
• What constitutes a reportable event
• Deviation examples
• Review of Office for Human Research Protections (OHRP) determination letters regarding deviations
• Links to useful resources

Deviations: What are they? Do you need to report? 2015 is intneded for:

• Healthcare interested in exploring the field of Clinical Research
• Human Subjects Research
• New Principal Investigator positions
• New Clinical Research Coordinator positions (1-2 years)
• Regulatory Compliance
• Administration in charge of Clinical Research