News By: Emily Norris

One of the most common and important types of quality management measures in clinical research is the Corrective and Preventive Action (CAPA) plan. Learning the CAPA process will provide insight into how corrective and preventive actions are handled, along with creating an effective game plan for your use of CAPAs. 

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. In an article for the forthcoming August issue of ACRP’s Clinical Researcher journal, Faith Holmes, MD, Chief Medical Officer, and Kristen Snipes, CCRA, Executive Director, Project Delivery, both with Elligo Health Research®, examine how, despite this increased awareness and regulatory push, many long-standing challenges persist.

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success. However, despite their frequent association, these terms embody distinct philosophies and practices. 

Hosting a robust onboarding process for introducing entry-level hires to their job responsibilities is clearly a best practice for any industry. Taking things one step further by onboarding both new and promoted employees who are at any step on their career ladder is proving to also be a wise move for the clinical research enterprise, says one experienced observer of trends in the profession. 

Study sites and sponsors could both benefit from learning to convert data from investigator meetings and other sources into meaningful metrics and actionable insights that can impact business strategy, a seasoned observer of the clinical research enterprise says.