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On April 29th, 2024 the US Food and Drug administration (FDA) posted a news release outlining an upcoming virtual listening session June 13th, 2024 from 9:00am–4:00pm ET, on the optimal use of and processes for FDA advisory committees (Ad Com). FDA Ad Coms are intended to provide the agency with advice and recommendations from the public as well as external experts from various backgrounds. They review the safety, effectiveness, and appropriate use of products in FDA regulated research by discussing scientific, technical, and policy issues and voting on proposed future actions.
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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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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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Clinical Research Professionals of North Carolina (a chapter of SoCRA also referred to as NC East or the RTP chapter)
Locations: For more information, click here.
Date: June 3, 2019
Time: 6:00 – 7:00 EDT
Topic: Workforce Gaps Post RBM: It is Time to “DIG” in!
Description:
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Did you miss the free live webinar on “Critical Thinking and Clinical Research – A Better Way”? Some key highlights of the training were:
What is critical thinking? To learn more about the seven critical thinking skills and how they relate to clinical research, sign up to view the recorded webinar here. DIGR-ACT® was built to support all of these.
Root Cause Analysis: There are many tools to find root cause, but they often lead down the wrong path, yielding inconsistent and ineffective results. For example, asking 5 Whys can result in different root cause depending on how the questions are asked, and what about other relevant questions such as who, what, where, when, and how?
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Effective Public speaking is integral to clinical research education/ communication. It impacts every aspect of study conduct.
The investigator educates the study patient on trial participation (via the informed consent) with an avid description of risks, benefits and patient responsibilities
The Clinical Research Associate (CRA) presents protocol procedural information to the study coordinators (SC) at the site initiation visit (SIV) to ensure accurate completion
The clinical trial manager (CTM) trains CRA staff on protocol endpoints to ensure credible data review/collection practices during monitoring visits
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The Department of Health and Human Services (HHS) is extending the comment period until June 3 for two proposed rules related to electronic health information and applicable to clinical trials. The HHS Office of the National Coordinator for Health Information Technology (ONC) has also released the second draft of the Trusted Exchange Framework and Common Agreement, which supports the exchange of electronic health information nationwide.
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Topic: ICH E6 Addendum R2 Team Training and Action Planning
Date: May 21, 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.
