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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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Over time, the clinical trial industry has figured out how to coordinate onsite monitoring of a study patient’s electronic health record. This can be through certified copies (very laborious for sites) or increasingly often by providing temporary secure access to source documentation for a particular trial.
Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.
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Join this live, interactive webinar with guest presenters from the Duke Office of Clinical Research within the School of Medicine for ‘A Case for Sponsor Monitoring Remote Access to EMRs.’ This session presents how a successful program was implemented prior to COVID-19 and then leveraged during COVID-19 to support sponsor remote review of EMRs while maintaining control and security of the subjects’ data and maintaining subjects’ privacy based on the HIPAA authorization. Learn about a case example of a successful program implementation that avoids site burden and maintains attributability to records. Explore opportunities for sites and sponsors to find similar solutions. The webinar concludes with a question and answer session.
