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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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Date: April 2, 2020
Time: 1:00 – 2:30 PM EDT
Live or available as recorded session
Register: Here
Background: The Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. It clarifies how to proceed with alternative methods of assessments that maintain subject safety and are in compliance with Good Clinical Practice (GCP), while minimizing risks to data integrity.
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Did you miss the free live webinar on “Critical Thinking and Clinical Research – A Better Way”? Some key highlights of the training were:
What is critical thinking? To learn more about the seven critical thinking skills and how they relate to clinical research, sign up to view the recorded webinar here. DIGR-ACT® was built to support all of these.
Root Cause Analysis: There are many tools to find root cause, but they often lead down the wrong path, yielding inconsistent and ineffective results. For example, asking 5 Whys can result in different root cause depending on how the questions are asked, and what about other relevant questions such as who, what, where, when, and how?
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Topic: New FDA Draft Guidance – A Risk-Based Approach to Monitoring of Clinical Investigations
Date: May 14, 2019
Time: 1:00 p.m. – 2:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
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Topic: Critical Thinking in Clinical Research and DIGR-ACT®
Date: May 7, 2019, space is limited to 100 participants! Sign-up Early.
Time: 11:00 a.m. – 12:00 p.m. EDT
Duration: 60 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
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Topic: ICH E6 Addendum R2 Team Training and Action Planning
Date: February 21, 2019
Time: 1:00 p.m. – 2:30 p.m. EST
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
