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EU Commission Releases Draft Annex 11: ...

12/02/2025

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On July 7, 2025, the European Union (EU) Commission and Pharmaceutical Inspection Co-operation Scheme (PIC/S) published an updated draft of Annex 11: Computerised Systems, a supplementary guideline that is part of the Good Manufacturing Practice (GMP). Although it is GMP focused, the guiding principles of the annex can also be applied to other GxP standards.

EU Commission Releases Draft Annex 11: Computerised Systems
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Warning Letter Issued to Investigator of ...

11/18/2025

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In July, 2025, the US Food and Drug Administration (FDA) issued a warning letter to an investigator conducting a clinical trial for pediatric participants. The warning letter was the result of a routine inspection part of the FDA’s Bioresearch Monitoring Program (BIMO) as well as the investigator’s written response to the Form FDA 483.

Warning Letter Issued to Investigator of Pediatric Study
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ISO Release DIS 9001:2026 for Quality ...

11/06/2025

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On August 27, 2025, the International Organization for Standardization (ISO) released a Draft International Standard (DIS) for the ISO 9001:2026 Quality Management Systems (QMS) to ISO member bodies for a twelve-week review and ballot period. The goal of ISO 9001 is to help organizations create and maintain consistency of their products or services and seeks to improve and refine their internal processes and procedures to increase efficiency.

ISO Release DIS 9001:2026 for Quality Management Systems
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Problems Found in Sponsor-Investigator Led Trial

10/30/2025

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On March 25, 2025 the U.S. Food and Drug Administration (FDA) issued a warning letter to the sponsor-investigator of a study due to objectionable conditions observed during a Bioresearch Monitoring (BIMO) Program inspection. The sponsor-investigator’s written response to the FDA Form 483 were deemed inadequate therefore the FDA issued a warning letter stating that the sponsor-investigator was noncompliant with multiple regulations within 21 CFR part 312.

Problems Found in Sponsor-Investigator Led Trial
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Sponsor BIMO Warning Letter – What is a Drug?

10/08/2025

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On April 30th, 2025, the U.S. Food and Drug Administration (FDA) issued a warning letter and Form FDA 483 to the sponsor of a clinical investigation as the result of a Bioresearch Monitoring Program (BIMO) inspection. 40 participants were enrolled in the study and took the investigational product that the sponsor claims was to help individuals with sleeping disorders without submitting an Investigational New Drug (IND) application.

Sponsor BIMO Warning Letter – What is a Drug?

Clinical Trial Risk & Performance Management vSummit Sept. 28th - 30th

7/20/2021

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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

Device Sponsor Warning Letter: No PMA or IDE

7/13/2021

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A recent US Food and Drug Administration (FDA) warning letter to a device sponsor involves the sponsor marketing a device used for dialysis without an approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). The device was previously cleared through the 510(k) pathway. However, the sponsor made significant changes to the design and function of the device.

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 1

7/06/2021

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DIGR-ACT® is a solution developed by industry experts that addresses the gap of critical thinking skills needed in the era of quality by design and risk management.

What does ‘D’ stand for?

Ever find when your team is trying to fix an issue that matters that you get a long way into the process before realizing each of you has a different idea of what the issue is? That's why we have ‘Define the issue’ as the first step of the unique DIGR-ACT® solution.

FDA IND Safety Reporting: New Draft Guidance

6/29/2021

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The US Food and Drug Administration (FDA) released a draft guidance “Sponsor Responsibilities - Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies.” The draft guidance is a combination of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies” and an updated version of the draft guidance from 2015, “Safety Assessment for IND Safety Reporting,” which has been withdrawn. The intent of the draft guidance is to clarify and support sponsors in understanding the requirements for expedited safety reporting.

Updated EMA GCP FAQ Guidance: Medical Records Inspection

6/22/2021

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The European Medicines Agency (EMA) Good Clinical Practice Frequently Asked Questions (FAQ) webpage offers guidance on GCP and is updated regularly as additional questions are received. A recently added question with answer regards the inspection of study participants’ medical records by regulatory authorities in the EU.

Question 15: “Do GCP inspectors from regulatory authorities of an EU/EEA Member State have the authority to inspect trial participants’ medical records and other data, even if there is no statement in the ICF establishing that trial participants consent to the review of their medical records and other personal data by EU inspectors?”