Wisconsin Chapter: Informed Consent Procedure: Lessons Learned from Inspection Findings
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11:00 AM - 12:30 PM - Webinar
Speaker: Janet Ellen Holwell, CCRC, CCRA, TIACR, FACRP
Clinical Research Consultant
Program Description: Informed consent irregularities remain one of the leading findings in U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) inspections. We will examine real-world examples of FDA Warning Letters addressing informed consent inspection findings, and discuss appropriate corrective and preventive actions (CAPA). Learners will come away with solutions to avoid common informed consent pitfalls, and ultimately, avoid inspection findings. Participants are encouraged to share their experiences as we discuss methods to aid in compliance through appropriate techniques for the informed consent process. Tools will be provided to assist in compliance.
Upon completion of this Webinar, attendees should be able to:
- Examine the major and critical inspection findings related to the informed consent procedure
- Discuss how to prevent major and critical inspection findings related to the informed consent procedure
- Implement the right corrective actions to resolve the major and critical inspection findings related to the informed consent procedure
Clinical research coordinators, clinical research staff
Once you register, you will receive the WebEx link.
Contact Robyn Furger, Chapter President, at firstname.lastname@example.org with questions.