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FDA BIMO Inspection Results in Warning Letter

02/19/2025

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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).

FDA BIMO Inspection Results in Warning Letter
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The Fourth Edition of ISO 14155 Coming Soon

02/04/2025

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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

The Fourth Edition of ISO 14155 Coming Soon
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New GCP Book Coauthored by Clinical Pathways ...

01/29/2025

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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.

New GCP Book Coauthored by Clinical Pathways Now Available
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New Draft Guidance on Protocol Deviation ...

01/21/2025

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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.

New Draft Guidance on Protocol Deviation Management Part 2/2
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ICH E6(R3) Progresses into Step Four

01/15/2025

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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).

ICH E6(R3) Progresses into Step Four

COVID

Onsite Monitoring Needed After Remote Monitoring? FDA Updates COVID-19 Clinical Trial Guidance

9/02/2021

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The US Food and Drug Administration (FDA) released an updated guidance, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”. As clinical research professionals navigate the long haul new normal, many are wondering if the remote monitoring that occurred during the pandemic shutdowns was adequate to meet regulatory requirements. The FDA continued to update the guidance as new questions arose. The new question added to the Questions and Answers section of the guidance is:

MHRA Guidance: Building Resilience into Clinical Trials

01/19/2021

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In March 2020, the Medicines and Healthcare Products Regulatory Agency (MHRA) of the United Kingdom released a guidance describing best practices for managing clinical trials during the COVID-19 pandemic. In November 2020, another guidance was issued describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic. The MHRA published this guidance to help the industry avoid interruptions caused by a persisting health crisis but also to support the applicable use of available flexibilities into routine procedures that better serve trial participants. The MHRA is asking us to build resilience into how we conduct clinical trials. One positive outcome from continuing clinical trials during the pandemic is that it has generated more evidence that remote monitoring using a risk-based approach is feasible and will likely remain a part of clinical trials moving forward.