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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?

Supporting Subject Safety and Comprehension with eConsent

11/21/17

The purpose of the Informed Consent Process is to ensure the subject’s understanding of the study prior to enrollment, to protect data integrity and the subject’s safety and rights, and to reduce noncompliance and study drop-outs. Paper consent forms have been used traditionally, but due to more complex clinical trials and longer, more complicated consent forms, they may not be the best option moving forward.

2018 Edition of the International Compilation of Human Research Standards Released

11/16/17

The 2018 edition of the International Compilation of Human Research Standards has been released by the Office for Human Research Protections (OHRP) and can be found here. The Standards compile more than 1,000 laws, regulations, and guidelines from 130 countries, including new countries to the 2018 edition Algeria, Madagascar, Mali, and Saint Lucia. The Standards were created for Sponsors, Investigators, Ethics Committees, and other stakeholders in clinical research, globally. Social-Behavioral research is newly included in the 2018 edition of the Compilation.

ACRP RTP Fall Conference Announcement: Nov. 9-10, 2017

10/19/2017

SAM Sather, MS, BSN, CCRC, CCRA, Vice President of Clinical Pathways, LLC, will be speaking at ACRP: Research Triangle Park Chapter’s 18th Annual Fall Conference on Friday, November 10, 2017.

Topic:         “Perspectives in Clinical Research"

When:        Thursday, November 9 – Friday, November 10, 2017

Where:       North Carolina Biotechnology Center (map)