Training Course Syllabus:

Protocol Deviations: Documenting, Managing and Reporting Webinar

Objectives of the Presentation

Define protocol deviations
Review the requirements for reporting such events to regulatory authorities
Review ICH guidelines and Good Clinical Practice (GCP)
Discuss Department of Health and Human Services (DHHS) guidance
Delve into Food and Drug Administration guidance

Why Should you Attend

Clinical investigators are required to conduct a clinical trial according to the research protocol. Most research protocols are written for an ideal world but the studies are carried out in the real world. This creates deviations, whether planned or unplanned. It is important to know what current expectations are regarding reporting to regulatory authorities to avoid non-compliance issues which can create delays in the conduct of research.

Areas Covered

FDA Determination Letters regarding deviations
Definition of a deviation
What ICH, DHHS and FDA say about deviations
Types of deviations
Review of institutional guidance documents
Examples
References

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, Clinical Research Coordinators, Associates, and Managers, Administration in charge of Clinical Research, Clinical Research Sites, Contract Research Organizations, Regulatory Coordinators, Principal Investigator positions, Sub-Investigators

Seminar Summary:

Deviations have often been misunderstood, misclassified and misreported. This webinar will help you to answer questions about deviations such as: What is a deviation? What’s the best way to manage deviations? Can they be avoided? What is their importance? Does deviations impact subject safety or data integrity? How can the research team anticipate, manage, and minimize the impact of protocol deviations? (see full course description)

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