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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New Draft Guidance on Protocol Deviation ...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

COVID-19

Onsite Monitoring Needed After Remote Monitoring? FDA Updates COVID-19 Clinical Trial Guidance

9/02/2021

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The US Food and Drug Administration (FDA) released an updated guidance, “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”. As clinical research professionals navigate the long haul new normal, many are wondering if the remote monitoring that occurred during the pandemic shutdowns was adequate to meet regulatory requirements. The FDA continued to update the guidance as new questions arose. The new question added to the Questions and Answers section of the guidance is:

How Do You Monitor Sites that Will Not Upload Source to Secure Repositories While Remote Monitoring? – Part 2

01/05/2021

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With no end to site restrictions in sight, sponsor/CRO monitors continue to look for guidance on best practices and logistics for remote monitoring during the pandemic. Our Clinical Leader article “Remote Monitoring In The Wake Of COVID-19 — Practical & Regulatory Considerations” has inspired related questions. Here is a sample of a recent one.

Question: Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct the SDV on certified source remotely.

Part 1 of the blog covered important details about sticky notes being used in monitoring. If you missed it, read more HERE.

What to Do with Unused IP Shipped to Subjects at Home? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on Dec. 4th

12/17/2020

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The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on what to do with unused investigational product (IP) shipped to study participants’ homes, a more common occurrence during stay at home orders and quarantines during the pandemic. The new question with answer makes it clear that regulations for IP accountability still need to be followed, but that alternative methods to traditional disposition can be considered.

Should We Treat the Safety Review of COVID-19 Study Participants Differently? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on September 21st

9/22/2020

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As sponsor or CRO monitors are continuing to monitor clinical trial sites remotely for the foreseeable future, additional clarification is needed for how to proceed while protecting subject safety and data integrity. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on the requirements for the investigator to review IND safety reports. The question and answer guidance shows how we must be very careful to not decrease the safety protection checks and balances we have in GCP between stakeholders.

Is it Really Consent? Considerations in Consenting COVID-19 Patients to Clinical Trials

8/11/2020

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During the pandemic, it has become evident that we must continue to consent COVID-19 patients into clinical trials as we work to discover treatment options and better understand other aspects of the disease. Because of isolation restrictions, it is more cumbersome for all involved to conduct the informed consent process as we are accustomed. The investigator or delegate is likely not permitted into the isolation room to discuss the aspects of the trial with the potential subject. This leads to barriers to their ability to see important facial features communicated during a conversation.