Updates in Informed Consent Guidance September 2012

Sep 7, 2012


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Course Description

The FDA has announced the release of a guideline for informed consent, “Guidance on Exculpatory Language in Informed Consent.” The guidance is aligned with the Office for Human Research Protections’ (OHRP) recommendations, and many useful examples are included. In this web seminar, we will review examples of Informed Consent Form (ICF) language, and discuss how to apply the recommendations of the guideline to ICFs.

VideoPreview

Learning Objectives

Navigate the regulatory climate related to the new guideline: Why the guidance?
Discuss the content of the guideline: What do you need to know?
Present the implications of the guideline on current practices and policy: How does it impact how you conduct clinical trials?

Who Should Attend

Research Site Managers
Investigators
Clinical Research Coordinators
Clinical Research Associates
Clinical Research Associate Managers
Project Managers
Sponsor/CRO Staff
Clinical Quality Compliance and Quality Assurance Professionals

Instructor

Nikki Christison, B.S.

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Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.

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