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In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
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On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
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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.
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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).
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A recent US Food And Drug Administration (FDA) investigator warning letter focused on record retention. According to FDA regulations, site records must be retained for at least two years after a marketing application is approved or two years after the study is closed (21 CFR 312.62(c)).
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The US Food and Drug Administration (FDA) released a draft guidance “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations” for public comment in December 2021. The draft guidance provides best practices for how digital health technologies (DHT) can be used to collect and support endpoint data and what information is needed in an investigational new drug application (IND) or an investigational device exemption (IDE) application that uses DHT. DHT is a “system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses.”
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The US Food and Drug Administration (FDA) issued a draft information sheet guidance “Frequently Asked Questions Statement of Investigator (Form FDA 1572)” as an update to the same titled guidance document from 2010. It provides clarification on when a waiver can be requested when an investigator outside the US cannot or will not sign a Form 1572. The purpose of the Form FDA 1572 is to collect applicable information from the investigators and sub-investigators at clinical research sites to verify they have the appropriate experience and background to conduct the clinical trial. Signing the 1572 is an agreement to conduct the clinical trial according to the applicable FDA regulations while protecting the safety and rights of the study participants and the quality of the data.
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During the pandemic, onsite FDA inspections were temporarily suspended starting in March 2020 and restarted late summer. Our blog “FDA Resumes Domestic Inspections” describes the risk-based approach to remote assessments during that time period. This in part explains the long interval since the last warning letter. The first new warning letter after inspections resumed was issued to an investigator.