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Live Webinar
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Assurances: What are they, Why and When do I need them
Date & Time: Thursday, February 28, 2013
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: Sarah Fowler-Dixon
Location: Online
Price : $195.00
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(for one participant)
Instructor Profile: Sarah Fowler-Dixon Education Specialist and instructor , Washington University
Overview: The Federal wide 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.
Areas Covered in the Session:
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Federal wide 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.
Click here to register for this webinar Who Will Benefit: l l l l
Principal Investigators / Sub-investigators. Clinical Research Scientists (PKs, Biostatisticians,) Safety Nurses Clinical Research Associates (CRAs) and Coordinators (CRCs)
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Recruiting staff QA / QC auditors and staff Clinical Research Data managers
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Human Research Protection professionals
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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. More recently, she lead a task force in the development of the Community Engaged Research Program at Washington University. ....more
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