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.
In this session, we will discuss what the current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research. This presentation is designed to define protocol deviations and review the requirements for reporting such events to regulatory authorities.
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.In this session, we will discuss what the current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research. This presentation is designed to define protocol deviations and review the requirements for reporting such events to regulatory authorities.
Learning Objective:
Those who attend this session should be able to identify a deviation and be able make an initial determination as to whether the deviation may be reportable to the Institutional Review Board (IRB).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
Course Provider
Sarah Fowler Dixon,
