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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.
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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.
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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.
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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.
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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.
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On October 1, a man from Richland, Washington was pronounced guilty of 47 counts of fraud and drug-related charges. Sami Anwar faces more than 28 years in federal prison according to the U.S. Justice Department’s Eastern District of Washington.
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The Food and Drug Administration (FDA) released a final guidance in November 2020, “Enhancing the Diversity of Clinical Trial Populations - Eligibility Criteria, Enrollment Practices, and Trial Designs.” Certain populations are underrepresented in clinical trials, even though they are part of the target audience for the investigational product once approved. The guidance outlines methods the sponsor can use to support more diverse enrollment that more accurately reflects the target population, in accordance with requirements in the FDA Reauthorization Act of 2017 (FDARA).
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On September 22, 2020, the US Food & Drug Administration (FDA) issued a release announcing the launch of the Digital Health Center of Excellence. The Digital Health Center of Excellence, a division of the Center for Devices and Radiological Health (CDRH), is designed to promote the advancement of digital health technologies by “providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.”
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Clinical Pathways has exciting news to share about our new partnership with Metrics Champion Consortium (MCC), a division of WCG. MCC will now offer 12 new eLearning courses on performance management and good clinical practice (GCP) developed by Clinical Pathways to provide high-quality, effective training resources for clinical research stakeholders.
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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 SDV on certified source remotely.
Question 1: But what about life before COVID and visits that occurred before? How do monitors verify that source questions (i.e., sticky notes on the binder left at a previous monitoring onsite visit) are addressed? How do you go about confirming the source is finished being monitored?
