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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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In June 2023, the U.S. Food and Drug Administration (FDA) issued a permanent debarment as required under the FD&C Act due to the grounds that the individual was convicted of a felony. The individual worked as a coordinator at a clinical site on studies over a variety of therapeutic areas. Their delegated tasks included administering procedures and maintaining case histories of the study participants.
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What: 4th Annual WCG MCC Clinical Trial Risk & Performance Management Collaborative vSummit
Sponsored by: Metrics Champion Consortium (MCC), a division of WCG
When: September 28th – 30th, 2021
Where: Virtual Summit (vSummit) is online
Register: HERE
Clinical Pathways is presenting and leading discussion groups on two topics:
1) Oversight of Monitoring – Are site issues mitigated? The day in the life of a site QMS and the gap in monitoring.
When: Wednesday, September 29, 2021 from 9:45 AM - 11:15 AM
Facilitators: Charles Sather, BSN, CCRA and Sandra "Sam" Sather, MS, BSN, CCRA, CCRC
2) RBQM Maturity Model – How to manage critical implementation components when they are maturing at a different pace? Small to large sponsor/CRO, implementation adaptability.
When: Thursday, September 30, 2021 from 9:45 AM - 11:15 AM
Facilitator: Sandra "Sam" Sather, MS, BSN, CCRA, CCRC CCRC
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Topic for Speaking Engagement and Panel Discussion: Central and Remote Monitoring: Leveraging Central and Remote Monitoring in Risk-Based Quality Management
Topic for Panel Discussion: Medical Device Trial Regulations, Quality and Data Management: Navigating a Changing Regulatory Landscape and Accelerating Approvals
Dates: March 2 - 4, 2021
Location: The virtual summit consists of pre-recorded sessions with live panel discussions and live Q&A sessions.
Register: https://register.healthtech.com/reg/scope
Sandra “SAM” Sather is:
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As clinical research professionals proceed to work around COVID-19 restrictions while maintaining GCP, questions continue to arise. On May 11th, the Food and Drug Administration (FDA) released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.
Some questions of note from the last two updates are:
