Achieving Research Compliance Through Risk Assessment

Speaker

Instructor: Sarah Fowler Dixon
Product ID: 704689

Location
  • Duration: 60 Min
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.
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info. Webinar All Access Pass Subscription

 

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

 

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.

Follow us :

 

 

Refund Policy

Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

+1-888-717-2436

6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube

 

Copyright © 2023 ComplianceOnline.com MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method