irbs and the changing landscape

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IRBs and the changing landscape www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

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Page 2: IRBs and the changing landscape

Instructor Profile

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

Sarah Fowler-Dixon, PhD, CIP is an 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.

Page 3: IRBs and the changing landscape

Description

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

This clinical research training will explain the Institutional Review Board (IRB) models. It will discuss the regulatory framework for IRB review including 21 CFR 50, 56 and 45 CFR 46.The number of clinical trials continues to increase. Clinical trials are no longer solely conducted at academic research centers or hospitals.

Page 4: IRBs and the changing landscape

Why should Attend

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

The number of clinical trials continues to increase. Clinical trials are no longer solely conducted at academic research centers or hospitals. Stand-alone facilities set up to conduct research are being established. Partnerships are being formed between traditional centers and the community.

Page 5: IRBs and the changing landscape

Objectives

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

IRB models, including IRB as the HIPAA Privacy Board Current issues surrounding IRB review Regulatory framework for IRB review: 21 CFR 50, 56 and 45 CFR 46 Assurances and agreements to facilitate IRB review Potential use of IRB Consortiums Accreditation and how this has changed IRBs

Page 6: IRBs and the changing landscape

Who can Benefit

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

Clinical Quality Assurance Professionals

Clinical Research Associates,

Project Managers, or others involved in

site and IRB assessment Clinical Investigators

Study Coordinators

IRB Members IRB Professionals

Clinical Research Coordinator

Page 7: IRBs and the changing landscape

How this Webinar works

www.onlinecompliancepanel.com | 510-857-5896 | [email protected]

Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat

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IRB Review