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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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The International Standard ISO 14155 “Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice” outlines what is considered good clinical practice for the design, conduct, recording, and reporting of clinical investigations of medical devices in human participants. As we enter 2025, a Draft International Standard (DIS) of ISO 14155 is in the final stages of the approval process and is expected to be released within the coming months to replace the existing ISO
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In November 2024, the CRC press published the first edition of “Good Clinical Practices in Pharmaceuticals” edited by Graham P. Bunn (President of GB Consulting, LLC) and authored by multiple clinical trial professionals, including Clinical Pathways’ own Jennifer Lawyer and Sandra “Sam” Sather. The book is a compendium of information regarding the Good Clinical Practice (GCP) guidelines including the standards, methodologies, laws, and regulations.
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The guidance breaks down the roles and responsibilities of the investigator, sponsor, and Institutional Review Board (IRB) in regards to monitoring, mitigating, reporting, and evaluating protocol deviations (PDs). The investigator, who is responsible for the conduct of the trial and protection of the rights, safety, and welfare of the participants must report all PDs to the sponsor, highlighting the important PDs.
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On January 6, 2025, the International Council of Harmonisation’s ICH E6(R3) for Good Clinical Practices (GCP) reached step four of the formal ICH procedure. This means that the ICH E6(R3) draft guidelines, since its release in May of 2023, were submitted to and approved by the ICH Regulatory Members of the ICH Assembly for adoption as an ICH Harmonised Guideline replacing E6(R2).
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In a recent investigator warning letter issued by the US Food and Drug Administration (FDA), an investigator was cited for failing to ensure an Institutional Review Board (IRB) that complies with the applicable regulatory requirements in 21 CFR 56 was overseeing their clinical trial. During the time where IRB approval for the protocol lapsed, the site continued to enroll and administer investigational products to study participants under that protocol. The investigator’s response to the FDA was inadequate because they explained that they did not need to report any adverse events during that timeframe.
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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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Now Available for Purchase: An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB eLearning
An Overview of 21 CFR 50 Human Subject Protection and 21 CFR 56 IRB interactive eLearning is now available for purchase in our online store HERE. The interactive eLearning course provides an overview of the key concepts and best practices for maintaining human subject protection (HSP) by following the U.S. Food and Drug Administration’s (FDA) applicable regulations. Conduct of a clinical trial involving human subjects includes considerations to protect their rights and safety. Ensuring HSP is a core principle of Good Clinical Practice (GCP) and is required by regulatory authorities. Understanding how to implement these FDA regulations applicable to clinical research is key to a successful and ethical clinical trial.
