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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FDA Issues Updated Draft Guidance on Use of ...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.

HIPAA

OCR Guidance on Audio Only Telehealth

06/21/2022

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U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) released “Guidance on How the HIPAA Rules Permit Covered Health Care Providers and Health Plans to Use Remote Communication Technologies for Audio-Only Telehealth” in June 2022, called “guidance on HIPAA and audio only telehealth” for clarity and brevity in this blog. This guidance clarifies how covered entities can provide audio only telehealth while complying with HIPAA Rules to protect the privacy and security of the participants or patients’ protected health information (PHI).

Digital Health Information: Applicable to HIPAA Breach Notification? Policy Statement Clarifies

02/08/2022

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Recently, many guidance documents and draft guidance documents regarding digital health information have been released. This is in response to the increase in numbers of devices used in the course of a clinical trial, including wearable devices, ePRO, eCOA, software such as apps, home monitors, etc. These devices collect health information and store or transmit it outside of the collection site. Such vendors need to be aware of how they are classified to ensure compliance with applicable regulations. If they are not directly considered a medical device, the device manufacturers and app developers may be considered vendors of personal health records (PHR) and would then need to comply with the Federal Trade Commission’s (FTC) Breach Notification Rule. The FTC released a Policy Statement to clarify the scope of this Rule.

Electronic Consent Now Available with FDA’s COVID MyStudies Application

6/09/2020

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Although electronic consent is permitted and encouraged by the Food and Drug Administration (FDA), many stakeholders have continued to use paper consents. Investigators have been having difficulties obtaining informed consent from subjects during the COVID-19 restrictions, especially from patients in isolation. The FDA developed the MyStudies application in 2018 as a tool to collect real-world data from subjects. Currently, it is available as the COVID MyStudies app in mobile device app stores for download. The app is intended to provide a reliable and regulatory-compliant way to obtain electronic informed consent.

OCR Update on HIPAA and COVID-19

5/19/2020

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The HIPAA Privacy Rule is frequently used as the reason for not allowing data to be shared, even when the participant’s HIPAA authorization states allowance of disclosing PHI, including remotely or virtually. The Office for Civil Rights (OCR) released a February Bulletin on HIPAA and COVID-19 to clarify how Protected Health Information (PHI) can be shared while still maintaining privacy during the crisis.

Webinar Recording: A Case for Sponsor Monitoring Remote Access to a Site’s EMR! Now Available for Purchase

4/30/2020

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Over time, the clinical trial industry has figured out how to coordinate onsite monitoring of a study patient’s electronic health record. This can be through certified copies (very laborious for sites) or increasingly often by providing temporary secure access to source documentation for a particular trial.

Purchase the recorded webinar here. Access to the recording is available for 10 days after purchase.