-
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.
-
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.
-
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.
-
On September 18, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance titled Demonstrating Substantial Evidence of Effectiveness Based on One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence to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.
-
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.
Topic: Contract Research Organization (CRO) Oversight after ICH E6(R2)
Date: January 22, 2019
Time: 1:00 p.m. – 2:30 p.m. EST
Duration: 90 minutes
Sponsored by: Life Science Training Institute
Webinar: Live interactive session. Recording will be available for 30 days.
Sign up here.
The U.S. Food and Drug Administration (FDA) published a Final Rule to the Federal Register on December 17, 2018. It will update 21 CFR 860: “Medical Device Classification Procedures” and will implement changes required by the 2012 FDA Safety and Innovation Act’s (FDASIA) amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Do you understand the difference between consent and centricity? Perhaps you already know that patient centricity is the process where the patient has control over information and are free to make choices they are comfortable with. Learn from subject matter experts about challenges to integrating patient centricity into clinical trials and how eConsent supports subject comprehension and decision making. Our own Sandra “SAM” Sather and an expert panel present information to help you support patient centricity with eConsent.
The regulations require investigators to have appropriate qualifications, but how to define it is not thoroughly described. Generally, sponsors or CROs have chosen to define qualification as completing training on Good Clinical Practice (GCP). Although having a knowledge of GCP is essential, the current method of training is not effective.
The U.S. Food and Drug Administration (FDA) issued a Notice of Proposed Rulemaking (NPRM) in the Federal Register, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations.” The NPRM seeks to amend regulations 21 CFR Parts 50, 312, and 812 in alignment with provisions in the 21st Century Cures Act (Cures Act).