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Archive: Informed Consent Content & Process Requirements
This web seminar presents the elements of the informed consent document and the components of the process. Industry specific scenarios are presented to reinforce important concepts, for example: Evaluating and documenting capacity to consent, voluntariness, when a HIPAA authorization is required, withdrawal of consent, and more. Discussions also include reported poor regulatory performance regarding informed consent, and successful solutions for practices that increase the protection of human subjects in clinical research.
- Examine required content of the Informed Consent Form (ICF): Are all stakeholders checking?
- Define the informed consent process per regulations and best practices
- Clearly define who and what determines if consent has been adequately executed
- Evaluate exceptions for obtaining consent, and the role of the research site, Institutional Review Board (IRB), and sponsor in the process
- Apply clear documentation of the informed consent process, including withdrawal of consent
- Review elements that must be included in an authorization for use and disclosure of protected health information
- Compare and contrast HIPAA authorization and the informed consent process
Who Should Attend
- Clinical Research Coordinators
- Site Research Managers
- Clinical Research Monitors
- Sponsor Project Managers
The course will be led by one of the following instructors:
Gary B. Freeman, M.S., C.C.R.A.
Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.