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

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).

• 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

Instructor Profile:

Dr. Sarah Fowler-Dixon,PhD, CIP has presented on various human subjects topics since 2001 at local, regional, and national conferences. She developed a comprehensive education program for human subject research which has served as a model for other institutions. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. Dr. Fowler-Dixon has served on various committees to improve research, procedures, community outreach, and retention.

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