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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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This workshop is for GXP professionals who are interested in adapting or adopting DIGR-ACT® into their operations to better support critical to quality factors and their quality system and how to train their teams in the DIGR-ACT® process.
Dates: Two part series (6 hours total) – Online live attendance mandatory
15 February 2022, 10:00 AM to 1:00 PM (EST)
AND
22 February 2022, 10:00 AM to 1:00 PM (EST)
Location: Live online
Registration: HERE
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Date: 27 January 2022
Time: 10:30 AM - 12:00 PM EST
Location: Interactive Webinar
Registration: HERE
Training on RCA does not usually happen, so many do not know how to carry out a proper RCA. Yet, it is an important step in understanding what happened so the issue(s) can be prevented from recurring. In this webinar, you will learn about a practical approach to RCA that shows results while encouraging critical thinking for GXP professionals.
These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change. Attendance at this or another session (live or recorded) is required before attending the Train-the-Trainer workshop scheduled for February 15 & 22.
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Dates: Two part series – Online live attendance mandatory
19 Oct 2021, 10:00 AM 1:00 PM (EDT)
AND
26 Oct 2021, 10:00 AM 1:00 PM (EDT)
Location: Live online
Registration: HERE
DIGR-ACT® is a process for you to integrate into your operations to better support critical to quality factors and your quality system in a rapidly changing environment. Better handling and prevention of issues that matter means better project outcomes and less tears!
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Date: September 16th OR 23rd, 2021. Choose which date works for you.
Time: 10:30 AM - 12:00 PM EDT
Location: Interactive Webinar
Registration: September 16 Registration HERE September 23 Registration HERE
Cost: AGXPE Member – $79.00
Non-Member Registration – $89.00
Clinical Pathways is pleased to announce a partnership with the Association for GXP Excellence (AGXPE). AGXPE will present the 90-minute interactive webinar hosted by Sam Sather and Keith Dorricott, founders of DIGR-ACT®.
This session will address the challenges in using root cause analysis to lead to effective risk assessment and CAPA for GXP. It will also introduce the challenges and gaps from a process approach standpoint related to integration of essential human performance factors and critical thinking process support. They include highlights of the current significant challenges to performing risk assessment and CAPA without a modern approach to root cause analysis.
These sessions introduce to the GXP audience to DIGR-ACT® as a solution to mature teams and processes in the era of big change.
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SAM Sather and Keith Dorricott co-authored an article published in Clinical Leader entitled, “Clinical Trial Root Cause Analysis: Can't We Do Better Than Five Whys?” If you have experience with Good Clinical Practice (GCP), you may know that ICH E6(R2) now requires sponsors to conduct a root cause analysis (RCA) and implement appropriate corrective and preventive actions (CAPA) for noncompliance “that significantly affects or has the potential to significantly affect human subject protection or reliability of trial results.”
