Deviations: What are they? Do you need to report? 2015 is a webinar that covers topics such as:
- 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
