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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New Draft Guidance on Protocol Deviation ...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

CRA

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.

Webinar Recording: A Case for Sponsor Monitoring Remote Access to a Site’s EMR! Now Available for Purchase

4/30/2020

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Over time, the clinical trial industry has figured out how to coordinate onsite monitoring of a study patient’s electronic health record. This can be through certified copies (very laborious for sites) or increasingly often by providing temporary secure access to source documentation for a particular trial.

Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.

Live Webinar: A Case for Sponsor Monitoring Remote Access to a Site’s EMR!

4/18/2020

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Join this live, interactive webinar with guest presenters from the Duke Office of Clinical Research within the School of Medicine for ‘A Case for Sponsor Monitoring Remote Access to EMRs.’ This session presents how a successful program was implemented prior to COVID-19 and then leveraged during COVID-19 to support sponsor remote review of EMRs while maintaining control and security of the subjects’ data and maintaining subjects’ privacy based on the HIPAA authorization. Learn about a case example of a successful program implementation that avoids site burden and maintains attributability to records. Explore opportunities for sites and sponsors to find similar solutions. The webinar concludes with a question and answer session.

Hiring New Clinical Researchers

9/17/2019

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In life, the purchase of a new car, or house, invokes feelings of excitement, potential value and sustainability.  Being new is positive thing, with infinite possibility.     

Whereas, in the clinical research industry, a new/inexperienced employee may invoke feelings of unease, and the investment of critical time and resources without prospective return. Wonderful possibility is not anticipated, rather, ability is questioned. This doubt forces the choice of experience over potential, on what is comfortable/predictable (such as the requisite two years of CRA experience for an entry level CRA position) over the unknown.

The Importance of Public Speaking in Clinical Research

5/21/2019

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Effective Public speaking is integral to clinical research education/ communication. It impacts every aspect of study conduct.

  • The investigator educates the study patient on trial participation (via the informed consent) with an avid description of risks, benefits and patient responsibilities

  • The Clinical Research Associate (CRA) presents protocol procedural information to the study coordinators (SC) at the site initiation visit (SIV) to ensure accurate completion

  • The clinical trial manager (CTM) trains CRA staff on protocol endpoints to ensure credible data review/collection practices during monitoring visits