Goal #1: Advance clinical and translational science

<a href="https://www.actscience.org/" target="_blank" rel="noopener noreferrer">Association for Clinical and Translational Science (ACTS)</a> is pleased to announce the results of their recent elections for the Board of Directors for 2024-2025. The board's role is to govern, establish policy, and make strategic decisions about the organization's future.&nbsp;The new board assumed office at the close of the Translational Science 2024 meeting on April 5, 2024...&nbsp;Read the full article <a href="https://www.georgetownhowardctsa.org/news-events/news/the-2024-2025-association-for-clinical-and-translational-science-acts-board-of-directors-election-has-shared-its-results" target="_blank" rel="noopener noreferrer">here</a>.

Georgetown-Howard Universities Center for Clinical and Translational Science

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Georgetown University

The 2024-2025 Association for Clinical and Translational Science (ACTS) Board of Directors Election Has Shared its Results

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Goal #6: Enhance training programs 

This open-access, self-study module series was created to address the need for quality management across the clinical trial lifecycle, as emphasized in the recent addendum to the ICH Guideline for Good Clinical Practice (GCP), E6(R2). The first two modules in this series cover monitoring and auditing clinical research sites. This third module is designed to provide the clinical research workforce with a fundamental understanding of the best practices for site inspections by the U.S. Food and Drug Administration (FDA). It also covers important factors and activities that the clinical research site staff should consider and complete before, during, and after the inspection. Additionally, the module provides guidance on what to do in case of receiving an FDA Form 483 and provides real scenarios with case studies.&nbsp;The RKS team spent around a year working on a module about site inspections conducted by the FDA. This module project was led by RKS Director, Chair and Associate Professor, Eunjoo Pacifici, Pharm.D., Ph.D., and other contributors including RKS Associate Director Nancy Pire-Smerkanich, D.R.Sc., M.S., and Administrators Karen Manrique, M.S., Annie Ly, M.S., Roxy Terteryan, M.P.H., and Gordon Wimpress. The team extracted content from various sources, such as the FDA, the National Institutes of Health, clinical research organizations, and the expertise and experiences of key stakeholders within the RKS group.&nbsp;The content was then recorded, edited, and produced by RKS Project Administrator Gordon Wimpress. The module is free and self-paced, and it is open to the entire clinical research workforce, as well as anyone interested in learning more about FDA site inspections. Upon completion of any of the modules, users receive a digital badge and a certificate of completion, which can be a great addition to resumes, CVs, and LinkedIn profiles…&nbsp;Read the full article <a href="https://sc-ctsi.org/news/sc-ctsi-regulatory-knowledge-and-support-core-launches-new-module-on-site-preparedness-for-fda-inspection" target="_blank" rel="noopener noreferrer">here</a>.

Southern California Clinical and Translational Science Institute

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University of Southern California

Southern California CTSI Regulatory Knowledge and Support Core Launches New Module on Site Preparedness for FDA Inspection

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Goal #7:  Training and career support programs for translational scientists

Congratulations to our the Case Western Reserve University Clinical and Translational Science Collaborative (CTSC) 2024 READI Themed Pilot Awardees! Requests were submitted for pilot research funding to increase diversity in clinical trials and enhance community engagement by addressing barriers to clinical trial participation. Ten pilot grants with awards up to $20,000 were presented to the following institutions and community organizations...&nbsp;Read the full article <a href="https://case.edu/medicine/ctsc/about-us/news-and-announcements" target="_blank" rel="noopener noreferrer">here</a>.&nbsp;

Clinical and Translational Science Collaborative at Case Western Reserve University

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Case Western Reserve University

Case Western Reserve University CTSC 2024 READI Themed Pilot Awardees

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The 2024-2025 Association for Clinical and Translational Science (ACTS) Board of Directors Election Has Shared its Results