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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SOCRA’s 2024 Annual Conference: Connection, Inspiration, and Innovation in Clinical Research

From September 27-29, 2024, clinical research professionals from around the world gathered in Las Vegas, NV for the SOCRA Annual Conference, a premier event dedicated to advancing knowledge and connections within our industry. Led by SOCRA Board President Laura Holtz, the conference offered attendees an immersive experience with highlights ranging from skill-building sessions to networking events and engaging keynote presentations. In reflecting on the event, Laura shared insights into the standout moments and key innovations that made this year’s conference a memorable and impactful gathering. 

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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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The Crucial Skills That All CRAs (Monitors) Need

Picture of AGA Finlayson, MA, MSc, Founder and Director of the White Wisteria Academy.

AGA Finlayson, MA, MSc

Found and Director

White Wisteria Academy

Abstract: In the heavily regulated world of clinical research, clinical research associates (CRAs) are generally receiving all of the training in hard skills that they need to understand their role. What is often missing is training in the soft skills that will help them deal with the demands of the job, increase each CRA’s job satisfaction, and reduce churn (staff turnover), while allowing CRAs to have a healthy work-life balance. Examples of crucial soft skills include assertiveness, listening, and task efficiency. This article describes two pictures of a CRA’s life: one without these soft skills and one with soft skills training. This will illustrate the importance of paying attention to soft skills and offering CRAs appropriate training in soft skills along with training in hard skills.

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Celebrating Clinical Research Excellence with 2024 President’s Award Winner Dan Redline, BA, CCRP 

The global clinical research community will gather in Las Vegas from September 27-29, 2024, for the SOCRA Annual Conference. This year, we’re pleased to honor Dan Redline with the President’s Award, recognizing his extraordinary contributions and dedication to advancing clinical research. 

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Finding Success and Belonging at the SOCRA Annual Conference: A First Time Attendee’s Experience 

Holly Crandall

BSN, RN, CCRP

Indiana University School of Medicine

This time last year, I was unsure if traveling to Montreal for the SOCRA Annual Conference would be a worthwhile investment in my career. As a research nurse, I’ve attended several conferences specific to my clinical field, which provided valuable knowledge about the disease states I work with. However, the SOCRA Annual Conference was different. It offered new tools and ways of thinking about my daily work. Entering a poster into the Poster Program also gave me a greater sense of involvement. I left energized by the passion of the other participants and excited for this year’s conference in Las Vegas. 

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Strategies to Promote Inclusion and Decrease Language Barriers in Spanish Speaking Participants

Ariana Berrios, EMT, Thomas Jefferson University

Picture of Emily Navarreto, BS, Thomas Jefferson University.

Emily Navarreto, BS

Thomas Jefferson University

Picture of Nancy A. Wintering, LCSW, CCRP, Thomas Jefferson University.

Nancy A. Wintering, LCSW, CCRP

Thomas Jefferson University

Abstract: This paper was developed from our discussions about inclusion of non-English speakers in clinical research. We presented a poster on this topic at the 2022 SOCRA Annual Conference. We believe that Spanish-speaking individuals are often excluded from clinical research studies because of language barriers. While some language services have been established for clinical use, those services are often unavailable and are generally not standardized for clinical research purposes. This paper calls attention to current language barriers and provides an overview of the shortcomings of Spanish language services in clinical research. The authors propose strategies to promote research that is inclusive of Spanish-speaking participants. While the emphasis of this paper is focused on improving inclusion of Spanish-speaking participants in clinical research; the solutions we propose could be applied to other participants whose first language is not English.

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Creating a Professional Workplace

Picture of Barbara van der Schalie, senior clinical research training manager and clinical monitoring research program directorate for Frederick National Laboratory for Cancer Research.

Barbara van der Schalie, MA

Senior Clinical Research Training Manager

Clinical Monitoring Research Program Directorate

Frederick National Laboratory for Cancer Research

Abstract: Professionalism is a key component of a dynamic, thriving workplace and a defining element of a productive workplace culture. As clinical research becomes more generationally diverse, professionalism standards are becoming less consistent. This article describes the changing concepts of professionalism, how it is judged, and how to optimize professionalism to benefit individuals and organizations.

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What it Means to Be a SOCRA Member

SOCRA membership signifies a commitment to excellence in clinical research. We unite a global community of over 15,000 members across 58 countries, all dedicated to advancing clinical research practices and fostering professional growth. Whether you’re a seasoned professional or new to the field, SOCRA offers invaluable opportunities for learning, networking, and making a meaningful impact. 

 
In this post, we’ll highlight what it means to be a SOCRA member, showcasing how our community collaborates to drive innovation, share knowledge, and elevate standards in clinical research, ultimately shaping the future of healthcare worldwide. 

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Workforce Development Transformation and Implementation: The Critical Role of Leaders in Success

Picture of Erika Stevens, faculty lecturer at Rutgers Clinical Research Management and Principal of Recherche Transformation Rapide. LLC

Erika Stevens, MA, FACRP

Faculty Lecturer

Rutgers Clinical Research Management

Principal

Recherche Transformation Rapide LLC

Picture of Liz Wool, President of Wool Consulting Group, Inc.

Liz Wool, FACRP, CCRA, CID, CMT

President

Wool Consulting Group, Inc.

Abstract: The role of leaders in successful implementation of a workforce development program is often overlooked. Notably, change management and the leader’s fluency in implementing change is necessary for success. This article describes the critical attributes for leaders to be able to manage and implement workforce development for their organizations, and for leveraging transformation management principles and practices for success.

Disclosure: The authors have no relevant financial relationship(s) in connection with this article.

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