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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New Draft Guidance on Protocol Deviation ...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

Investigator

Concerning Violations: Sponsor-Investigator Warning Letters

11/09/2021

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There are two recent warning letters relating to sponsor-investigators. (warning letter 1 HERE and warning letter 2 HERE). A sponsor-investigator both initiates and conducts a clinical trial, which is also known as an investigator initiated clinical trial (IIT). In both examples, the investigator used protocols internal to the institution but did not submit an Investigational New Drug (IND) application to the FDA. The drugs chosen for the protocols were approved and being used for on label use in the protocols. However, the protocols restricted what drug was being used and so could not be considered standard of care.

Comment Now! FDA Draft Guidance on Investigator Responsibilities for Safety Reporting

10/12/2021

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The US Food and Drug Administration (FDA) released a draft guidance, “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices” in September 2021. It combines recommendations from the 2009 procedural final guidance, “Adverse Event Reporting to IRBs - Improving Human Subject Protection” and the investigator responsibilities for adverse event reporting portion of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies”. This draft guidance clarifies how investigators can comply with their regulatory safety reporting requirements and understand when safety data may show reportable issues including serious adverse events (SAEs) or unanticipated adverse device effect (UADE).

Updated Sponsor CPGM: Focus on Remote Monitoring, CRO Oversight, Electronic Systems

9/28/2021

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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.

MHRA Updates EHR Remote Access Monitoring Guidance

9/21/2021

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The Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) updated their guidance document, “Access to Electronic Health Records (EHR) by Sponsor representatives in clinical trials” in September 2021. Originally released in November 2020, it did not provide adequate guidance on direct remote access of EHR. Other relevant guidance only included small sections on remote monitoring, including the March 2020 guidance describing best practices for managing clinical trials during the COVID-19 pandemic and the November 2020 guidance describing how to minimize disruptions in the conduction and integrity of clinical trials amid the ongoing pandemic.

Sponsor-Investigators Frequently Cited in FDA Warning Letters. Do You Know What Is Required for a High Quality Trial?

8/17/2021

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What are investigator initiated trials, and are they truly initiated by investigators, or by industry sponsors? Investigators may have an idea for a clinical trial with an investigational or approved product. Such trials can help answer important questions about medical products and devices. When investigators initiate the clinical trial, they also must fill the role of a sponsor. A sponsor-investigator conducted clinical trial is also known as an investigator initiated trial. From the regulatory side, there is not a lot of guidance on such trials, but there is a focus on them for inspections. The sponsor-investigator is ultimately responsible for the regulations that are applicable for sponsors AND investigators. Do you know which regulations and guidelines are applicable and that they have different definitions?