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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.
In response to questions about travel reimbursements, the Food and Drug Administration’s (FDA) Office of Good Clinical Practice published an updated Information Sheet on January 25, 2018, retitled “Payment and Reimbursement to Research Subjects” to reflect the clarifications. Stakeholders for this guidance are Institutional Review Boards (IRB) and Investigators.
Informed Consent is the process of ensuring the subject’s understanding of the study prior to enrollment, and eConsent may be one step in that process. Not only is Informed Consent a regulatory requirement for subject safety, but well-informed subjects are more likely to enroll and remain compliant, positively affecting enrollment numbers, reducing study costs, and protecting data integrity. eConsent supports the site’s efforts in fully informing subjects. As eConsent gains in popularity, it is important to understand some key benefits and considerations prior to adoption.
The U.S. Department of Health & Human Services (HHS), has posted a new listing of 27 social-behavioral research laws and regulations recently on their website. The standards posted were developed in several countries around the world like Australia, Canada, France, India, Saudi Arabia, South Africa, Taiwan, and the United States (U.S.). One of the regulations issued was implemented by the United Nations Educational, Scientific and Cultural Organization (UNESCO) and they must be followed by any site conducting a study being funded by the governmental agency.
On February 28, 2018, the FDA released E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry, which can be found here. Other than a few minor clerical differences, the guidance was implemented in entirety from the ICH E6(R2) Addendum, which can be found here. The notice of the draft guidance was published in the Federal Register on September 29, 2015 and was open to comments until November 30, 2015. The final draft was submitted to ICH Assembly and the regulatory agencies endorsed it in November 2016.
Speakers:
Sandra “SAM” Sather, MS, BSN, CCRA, CCRC (Regulatory and Quality, CRF Health)
Elizabeth Weeks-Rowe, LVN, CCRA (Clinical Research Consultant)
Deborah Rosenbaum, CCRA, CCRC, FACRP (President, Sarrison Clinical Research)
Podcast:
Listen to an informative glimpse into the upcoming eConsent webinar with a podcast available here.
