ComplianceOnline

Achieving Research Compliance Through Risk Assessment

Instructor: Sarah Fowler Dixon
Product ID: 704689
  • Duration: 60 Min
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Read Frequently Asked Questions

This training program will analyze the importance of research risks defined in 21 CFR 50 and 45 CFR 46. It will delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50. The program will also discuss the need for indemnification language in consent forms based on risk levels.

Why Should You Attend:

All researchers want their studies to be reviewed and approved quickly. The level of risk assigned a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed, need for additional protections, frequency of review, consent requirements, negotiation of indemnification language and several other factors.

This webinar will focus on understanding how risk levels are assigned and how making preliminary determinations when a study is proposed can help compliance officers, study coordinators, researchers and research administrators understand where the potential risk lies and how that will affect conduct of the study.

Attendees will also understand that risk determinations will provide explanations as to why there may or may not be flexibility in review and approval of studies. Knowing how these decisions are made and what they can affect will assist those who attend in conducting risk assessments of their own.

Areas Covered in the Webinar:

  • The importance of research risks defined in 21 CFR 50 and 45 CFR 46
  • Delve into how research risks affect IRB approval and review based on allowable actions in 21 CFR 50
  • Review consent possibilities as allowed by the regulations
  • Discuss need for indemnification language in consent forms based on risk levels
  • Consider how risks can be minimized by using preliminary risk assessments

Who Will Benefit:

  • Human Subjects Research
  • Clinical Research Coordinator Positions
  • Investigator Positions
  • Administration In-Charge of Clinical Research
  • Regulatory Compliance
  • Those involved in health plans and health care clearinghouses

Instructor Profile:

Sarah Fowler-Dixon, PhD, CIP, has been working with the Washington University IRB since May 2001. During that time, Dr. Fowler-Dixon has been a member of one or more of the reviewing committees, written and/or revised numerous guidelines and submittal forms, served on a data safety monitoring board, given hundreds of presentations on the ethics and regulations (HHS and FDA) of human subjects locally and nationally, been instrumental in starting and continuing the St. Louis IRB Consortium. She has chaired conferences, been involved in the CTSA grant, the NCI caBIG initative, the CITI Developer’s group and founded The Necessary Elements in the Fundamentals of Human Subjects Research course which continues today at Washington University. In addition, Dr. Fowler-Dixon has delivered a number of webinars and live sessions about a variety of topics related to the conduct and administration of human subjects research.

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