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Informed Consent Forms (ICF) for clinical trials are required to communicate the essential details of a trial to prospective participants including the procedures, the risks of using the investigational product (IP) or device, and actions the participant would be expected to take during the trial (i.e., filling out questionaries, coming in for routine visits, etc.). As clinical trials continue to evolve and become increasingly complex, ICFs must accurately explain these complexities as they can lead to confusion for the intended audience.
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The US Food and Drug Administration (FDA) published guidance on “Use of Data Monitoring Committees in Clinical Trials” in February 2024 which, once finalized, will take precedent over the FDA’s previous guide on the subject from 2006. The guidance clarifies data monitoring committees’ (DMC) relevance and importance in clinical trial oversight, and how to determine when utilizing a DMC is practical for certain clinical trials.
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On October 20, 2023, the FDA issued an investigator warning letter to Maria W. Greenwald, M.D.. The inspection was part of the FDA's Bioresearch Monitoring Program, aimed at assessing research conduct to safeguard the rights, safety, and well-being of human subjects. The investigation was conducted for several clinical studies, and there were multiple instances where the site failed to comply with investigational plans.
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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to provide further detail on the accepted types of confirmatory evidence used to support the results of one adequate and well-controlled clinical investigation.
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On September 6, 2023 the US Food and Drug Administration (FDA) issued a bulletin announcing three new draft guidances regarding the FDA’s Center for Devices and Radiological Health’s (CDRH) 510(k) premarket submission program to verify that the medical device to be marketed is substantially equivalent to a legally marketed device as medical devices continue to become more complex and innovative.
Since March 29th 2017 when the United Kingdom (UK) notified the European Council of its intention to withdraw from the European Union (EU), the clinical research industry has been wondering about the implications of this unprecedented withdrawal particularly since the European Commission and EMA believe that the UK will no longer participate in the EMA’s work after March 30th of 2019.
Date: May 15, 2017
Time: 1pm - 2:30pm EST
Duration: 90 Minutes - Online
Sponsored by Life Science Training Institute
Description:
Pediatric clinical trials present unique challenges since minors, as a vulnerable population, require a variety of regulatory protections to be incorporated as part of the study’s design, recruitment strategies, and monitoring plan.
Date: April 20, 2017
Time: 11:00 am EST | 15:00 GMT
Join us and CRF Health on this upcoming webinar hosted by Xtalks. We'll discuss the following benchmarks from the State of eConsent 2017 Report: https://attendee.gotowebinar.com/register/5600985180645861634
“Q: If local policy differs from the region’s regulations pertaining to the conduct of a clinical trial at a research site, what should be followed? A: The strictest requirements”. In response to this question one may ask, where can I find the local regulations for my study? A situation compounded in multinational trials. A helpful tool to reference is the OHRP’s International Compilation of Human Research Standards which was first published on 2005.