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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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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 an updated Compliance Program Guidance Manual (CPGM) for sponsors in September 2021. CPGMs are used to guide FDA inspectors when conducting an inspection for subject protection and data quality and integrity as part of FDA's Bioresearch Monitoring Program (BIMO). Part III, Inspectional, is vastly expanded in line with the current way clinical trials are conducted, including remote monitoring, sponsor’s outsourcing of clinical trial activities, and clinical trials conducted outside the United States. The CPGM increases scrutiny of sponsor processes and procedures related to selection of investigators, electronic systems, and CRO oversight. The following are selected highlights of the changes.
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The US Food and Drug Administration (FDA) requires sponsors to register and report results to ClinicalTrials.gov (Clinical Trials Registration and Results Information Submission Final Rule). The purpose of listing and reporting in the public database is to increase transparency and increase scientific understanding, thus allowing others to build on knowledge already gained rather than duplicating work that may be unnecessary. If these requirements are not met, the FDA has authority to take enforcement action.
