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CDER Unveils Center for Clinical Trial ...

04/30/2024

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On April 15th, 2024 the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA) announced the establishment of the CDER Center for Clinical Trial Innovation (C3TI). Clinical trial design and conduct must be held to rigorous standards and policies in order to safeguard the well-being of trial participants and the public. These standards and policies are outlined within the ICH E8(R1) Guideline: General Considerations for Clinical Studies.

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Improving Clinical Trial Patient’s ...

04/09/2024

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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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FDA Issues Updated Draft Guidance on Use of ...

04/02/2024

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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.

Amanda Dzengeleski
FDA Issues Warning Letter for Clinical ...

01/03/2024

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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.

Amanda Dzengeleski
FDA Releases New Draft Guidance on Confirmatory ...

09/27/2023

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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.

FDA Digital Health Center of Excellence & SaMDs

11/17/2020

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On September 22, 2020, the US Food & Drug Administration (FDA) issued a release announcing the launch of the Digital Health Center of Excellence. The Digital Health Center of Excellence, a division of the Center for Devices and Radiological Health (CDRH), is designed to promote the advancement of digital health technologies by “providing technological advice, coordinating and supporting work being done across the FDA, advancing best practices, and reimagining digital health device oversight.”

How Do You Monitor Sticky Notes at the Site While Remote Monitoring? – Part 1

11/03/2020

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Many sites now use eReg vendors such as Veeva, Florence, RealTime, etc. as a source document depository database for monitors to review and leave source questions within. This allows the monitors to conduct SDV on certified source remotely.

Question 1: But what about life before COVID and visits that occurred before? How do monitors verify that source questions (i.e., sticky notes on the binder left at a previous monitoring onsite visit) are addressed? How do you go about confirming the source is finished being monitored?

Comment Now! FDA Draft Guidance on PRO Instruments

10/27/2020

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The Food and Drug Administration (FDA) recently released a draft guidance entitled “Principles for Selecting, Developing, Modifying and Adapting Patient-Reported Outcome Instruments for Use in Medical Device Clinical Evaluation.” This draft guidance follows a guidance from 2019, “Patient-Reported Outcome Measures: Use in Medical Product Development to support Labeling Claims”, and a push starting in 2016 by the Center for Devices and Radiological Health (CDRH) to incorporate the use of patient-reported outcomes (PROs) in evaluating medical devices.