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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?

Comment Now! RWE Using Electronic Health Record and Medical Claims Data Draft Guidance

10/26/2021

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The US Food and Drug Administration (FDA) released a draft guidance on “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products.” This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Part of the Cures Act is related to the use of real-world evidence (RWE) to help support the approval of a new indication for an approved drug or to support post approval study requirements.

Now Available for Purchase: HIPAA Training for Clinical Trial Professionals

10/19/2021

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HIPAA's requirements for the use and disclosure of Protected Health Information (PHI) during the conduct of a clinical trial is not simple and depends on the situation. But there is a way to use a core set of principles and questions that provide an ability to manage and facilitate the needs of all stakeholders. The regulatory authority of HIPAA, the OCR and FDA, agree that the two sets of regulations do not conflict and work well together. HIPAA does not restrict the GCP requirements of a site.

To purchase to to view an interactive demo, visit our online store HERE.

Comment Now! FDA Draft Guidance on Investigator Responsibilities for Safety Reporting

10/12/2021

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The US Food and Drug Administration (FDA) released a draft guidance, “Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices” in September 2021. It combines recommendations from the 2009 procedural final guidance, “Adverse Event Reporting to IRBs - Improving Human Subject Protection” and the investigator responsibilities for adverse event reporting portion of the final guidance from 2012, “Safety Reporting Requirements for INDs and BA/BE Studies”. This draft guidance clarifies how investigators can comply with their regulatory safety reporting requirements and understand when safety data may show reportable issues including serious adverse events (SAEs) or unanticipated adverse device effect (UADE).

DIGR-ACT® Critical Thinking Focuses on Addressing the Right Issue or Risk at the Right Level – Part 6

10/05/2021

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What does ‘C’ stand for?

Do you care whether the actions you took to try to stop an issue from recurring were completed? Does it matter if they actually worked? Of course! Deciding on actions is only part way to fixing a problem. We need to complete the actions and make sure they were effective. That's why there is the ‘C’ step in the DIGR-ACT® solution, where C stands for ‘Check’.

Updated Sponsor CPGM: Focus on Remote Monitoring, CRO Oversight, Electronic Systems

9/28/2021

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The US Food and Drug Administration (FDA) released an updated Compliance Program Guidance Manual (CPGM) for sponsors in September 2021. CPGMs are used to guide FDA inspectors when conducting an inspection for subject protection and data quality and integrity as part of FDA's Bioresearch Monitoring Program (BIMO). Part III, Inspectional, is vastly expanded in line with the current way clinical trials are conducted, including remote monitoring, sponsor’s outsourcing of clinical trial activities, and clinical trials conducted outside the United States. The CPGM increases scrutiny of sponsor processes and procedures related to selection of investigators, electronic systems, and CRO oversight. The following are selected highlights of the changes.