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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On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
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This workshop is for GXP professionals who are interested in adapting or adopting DIGR-ACT® into their operations to better support critical to quality factors and their quality system and how to train their teams in the DIGR-ACT® process.
Dates: Two part series (6 hours total) – Online live attendance mandatory
15 February 2022, 10:00 AM to 1:00 PM (EST)
AND
22 February 2022, 10:00 AM to 1:00 PM (EST)
Location: Live online
Registration: HERE
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The US Food and Drug Administration (FDA) released a draft guidance “Considerations for the Use of Real-World Data and Real-World Evidence To Support Regulatory Decision-Making for Drug and Biological Products” for public comment in December 2021. This draft guidance is published as part of a series of real-world evidence (RWE) guidance 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 regulatory decision making, including the approval of a new indication for an approved drug or to support post approval study requirements. This draft guidance discusses its applicability in using RWE in clinical trials and observational studies.
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The US Food and Drug Administration (FDA) released a draft guidance “Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products” for public comment in November 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). A good source of RWE, a registry is an “organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.”
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The US Food and Drug Administration (FDA) released a draft guidance “Data Standards for Drug and Biological Product Submissions Containing Real-World Data” for public comment in October 2021. This draft guidance is published in line with the 21st Century Cures Act (Cures Act). Comment now through January 21, 2022 HERE.
What does ‘T’ stand for?
Everyone talks about learning from when things go wrong. People say it's the best way to learn, but it's not always easy. The DIGR-ACT® solution gives you a way. By taking you through the issue to the root cause, actions and then making sure the actions work, you have learned from the issue. Maybe your learning can be transferred to others? Perhaps the same problem happens to other people too?