Overview:

Deviations have often been misunderstood, misclassified, and misreported. Adding to the confusion is terminology that has been applied to deviations, leaving the study team, the study monitors, and the IRB confused about what a deviation is and how to handle a deviation.

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. So, 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.

This webinar is designed to define protocol deviations and review the requirements for reporting such events to regulatory authorities.

Areas Covered in this Webinar:

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 IRB guidelines documents
Review of Office for Human Research Protections (OHRP) determination letters regarding deviations
Deviation reporting examples
Links to useful resources

Learning Objectives:

Identify a deviation
Make an initial determination as to whether the deviation may be reportable to the Institutional Review Board (IRB)

Who Will Benefit:

Human Subjects Research
Healthcare Personnel interested in exploring the field of Clinical Research
New Clinical Research Coordinator Positions
New Principal Investigator Positions
Administration in charge of Clinical Research
Regulatory Compliance Personnel

Speaker Profile:

Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program.

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.

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