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Assurances: What are they, Why and When do I need them

Event Details

Assurances: What are they, Why and When do I need them

Time: November 17, 2017 from 10am to 11am
Location: Online
Street: 161 Mission Falls Lane, Suite 216
City/Town: Fremont
Website or Map: http://www.mentorhealth.com/c…
Phone: 8003851607
Event Type: webinar
Organized By: Netzealous LLC -MentorHealth
Latest Activity: Oct 10, 2017

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Event Description

Training Options  Duration: 60 Minutes  
Friday, November 17, 2017   |   10:00 AM PDT | 01:00 PM EDT

Overview:    The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an institution who has filed such an agreement. One of the terms deals with written agreements for non-affiliated investigators and institutions. When a researcher "engages" a site or individual not currently governed by his/her home institution, the researcher has the option of asking the non-affiliated site or individual to obtain a separate IRB approval or to request that his home institutional review board become the IRB of Record.

Once this request is made, the potential IRB of Record must gather certain information and require certain written agreements in order to become the IRB of Record. More often than not, when researchers establish partnerships, little thought is given to regulatory ramifications of that partnership and thus finding themselves frustrated at the thought of having to provide additional information, gather additional signatures, and explain this regulatory requirement to their partners. Attending this webinar will provide you with information that can be passed along to partners to better explain the process.

Why should you Attend: Most investigators do not think about additional regulatory criteria when designing a study. The current trend is conduct research in private physician offices and other community venues. Although this makes research more accessible to potential participants, it also invokes another set of regulations and requirements. The one that many investigators and their potential research partners struggle with are the written agreements required by the institutional review board (IRB), namely the individual investigator agreement (IIA), IRB authorization agreement (IAA), and the Federalwide Assurance (FWA).



Areas Covered in the Session:

Federalwide Assurance
Individual Investigator Agreement
IRB Authorization Agreement
When these agreements are used
Why these agreements are used
The process for establishing these agreements
Are there other types of agreements that institutions may enter into and how those would meet the regulatory framework

Who Will Benefit:
Principal Investigators/Sub-Investigators
Clinical Research Scientists (PKs, Biostatisticians)
Safety Nurses
Clinical Research Associates (CRAs) and Coordinators (CRCs)
Recruiting Staff
QA/QC auditors and Staff
Clinical Research Data Managers
Human Research Protection Professionals

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

Price - $139

Contact Info:
Netzealous LLC -MentorHealth
Phone No: 1-800-385-1607
Fax: 302-288-6884
Email: support@mentorhealth.com
Website: http://www.mentorhealth.com/
Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/

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