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

This webinar will help you clearly understand, classify and determine what deviations to report in clinical studies. It will also explain, in detail, the terminology applied to deviations. 

Why Should You Attend:

As the human subjects regulatory framework continues to grow and be further defined, it is important to know when and what needs to be submitted, reviewed, and approved by an Institutional Review Board (IRB) prior to implementation by the study team. Alternatively, as studies become more complex and complicated the study team often has to make immediate decisions which may not allow time for a regulatory consult.

Areas Covered in the Seminar:

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

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in:

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