Tag: Clinical Trials

Navigating the Critical Role of Quality Assurance in Clinical Trials: Best Practices, Challenges, and Emerging Trends

Viswakanth Makutam, Pharm D, Msc, ACRP-CP

The Role of Quality Assurance in Clinical Trials

Clinical Research Quality Assurance is a vital part of today’s successful clinical research, ensuring that research studies are run in compliance with regulatory requirements, following the guidelines that data integrity and patient safety are sustained. As new technologies and methodologies evolve in clinical trials every day, the role of Clinical QA becomes even more critical. In this blog, we will explore the essential aspects of Clinical QA, common challenges, some of the best practices, and evolving trends that define the scope of clinical research.

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REDCap Project Building: A Tool for the Distribution and Management of Research Surveys and Databases

Picture of Emily Navarreto, Clinical Research Coordinator at Thomas Jefferson University.

Emily Navarreto, BS

Clinical Research Coordinator

Thomas Jefferson University

Abstract: REDCap is a secure web application that was designed for building and managing online surveys and databases. This article focuses on the many benefits of REDCap for collecting research data. Topics covered include how to build a project, survey distribution, exporting data securely, and analyzing results. The variety of projects that can be built on the platform and how to effectively manage both individual and mass data collection are highlighted.

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Clinical Trials Day 2024: A Call to Reflect, Engage & Inspire

Clinical Trials Day is a moving reminder of the clinical research community’s pivotal role in shaping the future of the field. It’s a day of reflection for us to thank you and also a call to action, urging us to actively engage in advancing clinical research to drive innovation, improve patient outcomes, and enhance healthcare.

In this article, we’ll reflect on the successes of our SOCRA Chapter Volunteers to demonstrate the vast possibilities we can uncover together. For those who feel inspired to take action, chapter volunteers will share valuable tips for starting a local SOCRA chapter. These chapters empower local clinical research communities and provide a platform for personal growth and career development, enabling you to make a difference while fueling your professional aspirations.

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Celebrating Chapter Volunteers on Clinical Trials Day 2024 

As Clinical Trials Day 2024 approaches on May 20, we’re spotlighting the incredible work of our SOCRA chapter volunteers. These individuals dedicate their time and expertise to advance clinical research and foster community connections within our SOCRA chapter program.

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Leadership and Line Management in Clinical Research

Anatoly Gorkun
Senior Manager, Global Clinical Management, PPD
Hugh Devine
Senior Director, Global Clinical Management, PPD

Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and its workforce to deliver company objectives. This article provides an overview of line management styles and line-management-through-leadership approaches in the clinical research environment. The line management cycle – team building, support, motivation, and development—is described. Real-life examples illustrate how line management can support clinical research deliverables.

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Partnering with Patients to Accelerate Cancer Research: Count Me In

Sara Balch, author

Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard

Abstract: Count Me In is a research initiative whose aim is to engage patients living with all major cancer types, as well as those with rare cancers. Along with this goal, Count Me In hopes to bring about a cultural shift that empowers patients, researchers, and clinicians to work in partnership and accelerate medical progress by allowing  researchers to work directly with patients and advocacy groups along with software engineers and computational scientists, to collect, analyze, and share de-identified data. The combined power of thousands of individual experiences will assist researchers in understanding, why patients respond differently to treatments, uncover new genetic targets for therapies, and help propel groundbreaking discoveries that transform cancer care.

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Conducting Clinical Trials in Canada Inspections of Clinical Investigators

Clinical Investigator Inspections

Mike M. Rashti President, BIMO Auditor and Trainer, LLC

Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to prepare for an inspection and differences between inspections of clinical research sites in the United States and Canada are discussed. Protocol violations observed at Canadian sites that have been documented by FDA Form 483s (Inspectional Findings) and Warning Letters are noted in this article.

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Clinical Trials Day 2021: A Time for Celebration and Reflection

May 20th  marks Clinical Trials Day (CTD), an international commemoration of James Lind’s launch of the scurvy clinical trial on May 20, 1747, which would form the foundation for modern clinical research. Celebrated for the first time in 2005, CTD raises clinical trial awareness and honors clinical research professionals across the globe. In celebration of this distinguished occasion, we’ve continued our three-year tradition of inviting SOCRA Members to nominate each other for their outstanding work and contributions to public health, medical advancement, and improved health outcomes. We caught up with our first 2021 nominee to uncover her thoughts and insights on the significance of CTD and the clinical research industry as a whole.

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Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs

Michael Wieczerzak
Associate Director, Clinical Quality Management, EMD Serono


Abstract: Sponsors and contract research organizations should be using electronic clinical trial management systems to efficiently oversee their trials. This article describes the basic structure of clinical trial management systems and the need for these systems. Benefits of using an integrated clinical trial management system are highlighted, including the ability to link to other systems, running reports, and outputs such as executive management reporting dashboards, listings, and merged datasets. Requirements for compliance with 21 CFR Part 11 are described.

Disclosure: The author is not writing this article on behalf of his employer.

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Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            Senior Manager, Global Clinical Development, PPD UK

Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

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