-
In November 2024, the US Food and Drug Administration (FDA) issued a warning letter to the sponsor as a result of a BioResearch Monitoring Program (BIMO) inspection which observed objectionable conditions. The warning letter cited two violations of the Title 21 CFR.
-
In December 2024, following the release of the 2024 revision of the Declaration of Helsinki (DoH), US Food and Drug Administration (FDA) staff shared the FDA’s perspective on what their role was in the development of the 2024 DoH and how it may impact FDA procedures. The DoH is intended to guide clinical research involving human participants that is often used as the foundation for other guidelines such as the International Council for Harmonisation (ICH) Good Clinical Practice (GCP).
-
In October 2024, the World Medical Association (WMA) announced the adoption of the 2024 revision of the Declaration of Helsinki (DoH) during the 75th WMA General Assembly in Helsinki, Finland, the same location where the Declaration was initially adopted 60 years prior.
-
On September 27, 2024, the US Food and Drug Administration (FDA) issued a warning letter to an Institutional Review Board (IRB) as a result of a (BIMO) inspection from July of 2023. BIMO inspections evaluate compliance with of FDA regulatory requirements, in this case, title 21 CFR Parts 50, protection of human subject, and 56, Intuitional Review Boards.
-
On November 8, 2024, the US Food and Drug Administration (FDA) hosted a virtual public webinar for clinical research stakeholders as well as anyone interested in the informed consent process of clinical trials titled “Informed Consent – More than Just Another Document to Sign?”. As the title suggests, the webinar explores the standards for informed consent in FDA regulated trials, how they are impacting the trial participant’s experience, and how they can be innovated and improved upon.
-
There have been many questions about how to monitor clinical trials amid the changing landscape of COVID-19 restrictions. Remote monitoring is one of the ways of reducing onsite monitoring visits at a time of physical distancing and travel restrictions. Metrics Champion Consortium (MCC) launched the MCC COVID-19 Knowledge Sharing Group as an opportunity for MCC member organizations to share knowledge and to support one another during this uncertain time.
-
Our popular “Remote Monitoring Operations While Maintaining HIPAA, GCP, and COVID-19 Restrictions” webinar prompted many important questions, which we answered during the webinars. If you missed the webinar, a recording is now available for purchase. We also compiled a FAQ document to help guide your remote monitoring efforts during the crisis.
-
Clinical Trial Transformation Initiative (CTTI) collected information from clinical trials stakeholders in March during increasing COVID-19 restrictions. An ongoing concern is how to balance keeping subjects, sites, and monitors safe while deciding whether and how to continue clinical trials or if they should be placed on hold.
-
Because of the COVID-19 pandemic, the European Commission announced that the implementation of the Medical Devices Regulation (MDR) will likely be delayed by one year. There are limited resources currently available to implement the MDR by the original date of May 26, 2020.
-
Recently, the Food and Drug Administration (FDA) released a finalized guidance document for conducting clinical trials during the COVID-19 pandemic. Clinical trials are facing many challenges due to site closures, travel restrictions, and investigational product supply chain interruptions. The guidance clarifies how to proceed with alternative methods of assessments that maintain subject safety and are in compliance with Good Clinical Practice (GCP), while minimizing risks to data integrity. The FDA just issued an updated document with a Frequently Asked Questions section. The FDA will continue to update the document as new questions arise in the rapidly changing environment of the COVID-19 pandemic.
