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FDA Webinar on Improving the Informed Consent Process
02/26/2025
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On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
FDA BIMO Inspection Results in Warning Letter
02/19/2025
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On October 10, 2024, the US Food and Drug Administration (FDA) issued a Warning Letter to a clinical investigator due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection in 2023. The warning letter addresses multiple violations to Title 21 of the Code of Federal Regulations (CFR).
Improving Clinical Trial Patient’s Comprehension of Informed Consent Forms
04/09/2024
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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
FDA Informed Consent Final Guidance Finally Here!
08/16/2023
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The US Food and Drug Administration (FDA) published finalized guidance on “Informed Consent” August 2023. It finalized the “Informed Consent Information Sheet” which was previously in draft since July 2014 and supersedes the final guidance “A Guide to Informed Consent” from September 1998. It is applicable for IRBs, investigators, and sponsors.