Guest User
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
Guest User
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
Guest User
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New Draft Guidance on Protocol Deviation ...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New Draft Guidance on Protocol Deviation Management Part 2/2
Guest User
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

MCC Summit

RBQM Community Discussion Outcomes from MCC vSummit 2020

10/20/2020

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Sandra “SAM” Sather lead a community discussion at Metrics Champion Consortium’s (MCC) vSummit 2020 on “The Risk-Based Monitoring Training Gap,” related to her prerecorded session on “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb.” The conversation was informative as to where different organizations lie on the spectrum of implementing risk-based quality management (RBQM), with attendees from large sponsors explaining that they may have policies that require them to implement 100% source data verification (SDV) regardless of risk assessment for pre-phase III trials and attendees from small to mid-sized organizations commenting that they understand the need for risk-based monitoring plans but sometimes meet challenges cross functionally.

Clinical Trial Risk & Performance Management vSummit Sept. 8th - 12th

9/01/2020

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Sandra “SAM” Sather, VP of Clinical Pathways and a 2020 MCC Ambassador, is speaking on the topic “The RBM Training Gap: Risk-Based Monitoring the Noun vs. the Verb”. Have you heard "We are not doing RBM for this study . . ." What? Our quality system should support a risk-based approach to many clinical trial activities like site monitoring, data quality oversight, vendor oversight, safety surveillance, audit planning, and more.