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Study Risk and How it Affects Approval .pdf

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We Train Healthcare Professionals

Live Webinar on

Study Risk and How it Affects Approval
Date: Thursday, June 12, 2014

60 Minutes

Time: 10:00 AM PDT | 01:00 PM EDT
Location: Online

Register Now

Instructor: Sarah Fowler-Dixon

45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits
that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even
if not participating in the research)." How the study is designed can minimize potential risks to participants. Studies
that are deemed "minimal risk" have greater options when it comes to using an expedited review system and
options for consent.

Areas covered in the session:

What is risk assessment?


Why is risk assessment important?
How can you make preliminary risk assessments?


What does risk assessment affect?
What are some methods of reducing risks in a research study?

Who Will Benefit:



Principal Investigators / Sub-Investigators.
Clinical Research Scientists (PKs,
Safety Nurses
Clinical Research Associates (CRAs) and
Coordinators (CRCs)
Recruiting Staff
QA / QC Auditors and Staff
Clinical Research Data Managers
Human Research Protection Professionals

Click here to register for this webinar

About Speaker
Sarah Fowler-Dixon
Education Specialist and instructor , Washington University
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....

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