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In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
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In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
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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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Join Sandra “SAM” Sather as she presents an overview of the quality management of electronic systems in clinical trials for cross functional teams. It includes an important comparison of some of the FDA and EMA guidance and regulation, including recent guidance from EMA. This course can be used to conduct training for your teams and to help you plan and conduct a gap analysis of your current quality management system related to all stages of clinical trials.
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With clinical trial sites prolonging restricted access and sponsor or CRO monitors continuing to monitor clinical trials remotely, more clarification of how to proceed in the current environment while maintaining subject safety and data integrity and quality is needed. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on methods of obtaining informed consent from patients in isolation and an additional question and answer.
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Have you ever heard or stated, “We are not doing risk-based monitoring for this study”? This is using the term to refer to a style vs. a process to conduct monitoring based on risk. This means that there was a decision to conduct “traditional” monitoring, with 100 percent source data verification (SDV) and/or 100 percent data review of trial subjects.
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Originally released in March 2020, the Food and Drug Administration (FDA) revised their “Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” in June 2020. The guidance is applicable for the duration of the current pandemic. It is intended to further clarify how already marketed non-invasive medical devices may be used with COVID-19 patients to reduce transmission.
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Although electronic consent is permitted and encouraged by the Food and Drug Administration (FDA), many stakeholders have continued to use paper consents. Investigators have been having difficulties obtaining informed consent from subjects during the COVID-19 restrictions, especially from patients in isolation. The FDA developed the MyStudies application in 2018 as a tool to collect real-world data from subjects. Currently, it is available as the COVID MyStudies app in mobile device app stores for download. The app is intended to provide a reliable and regulatory-compliant way to obtain electronic informed consent.
