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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.
Link: http://resources.crfhealth.com/h/i/287066229-recruiting-and-retaining-patients-with-econsent/279183
The newly released joint FDA and OHRP electronic Informed Consent (eConsent) guidance addresses ways in which eConsent can facilitate the subject’s comprehension of the information presented during the consent process, such as explaining scientific and medical terms and the risks associated with participation.
3 Ways Electronic Informed Consent Benefits Trial Participants
There are some exciting things happening in clinical research; one of which is patient centric focused trials and improvements in informed consent. Electronic Informed Consent (eConsent) is here to help. One of the goals of eConsent is to support a subject become a successful participant leading to better patients and better data.
The FDA and the OHRP announced the finalized version of the regulatory guidance document for electronic informed consent (eIC) “Use of Electronic Informed Consent—Questions and Answers” December 2016. The guidance document represents the current thinking of these regulatory agencies and are recommendations, but like this one, sometimes include requirements where applicable. It is of note that the FDA and OHRP combined their guidance together into one document to support ongoing efforts to harmonize between the agencies. This is great news for those that consent under FDA regulated trials and / or government sponsored research! This emphasizes the point that an eIC solution needs to be flexible to support very simple to complex projects, as well as from high-risk treatment to non-interventional studies.
Link: http://resources.crfhealth.com/h/i/282742953-the-value-of-electronic-informed-consent/279183
Securing informed consent from clinical trial participants involves more than a signature — proper understanding is key! Consent has a major impact on regulatory compliance, enrollment rates and expenses across the life of your study.
Date: Dec 19, 2016
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
To Sign-up: http://www.lifesciencetraininginstitute.com/doc/monitoring-electronic-health-records-ehrs-0001
Description:
In this session we will take an in depth look to the recent May 2016 FDA Draft Guidance as well as we will provide clear, practical answers to Frequently Asked Questions about Monitoring Electronic Health Records (EHR) including
