Category: Trial Management

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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Using Evidence-Informed Practices to Improve eConsent

Authors: Annie B. Friedrich, PhD, Erin D. Solomon, PhD, Jessica Mozersky, PhD, & James M. DuBois, DSc, PhD

Author affiliation (all authors): Bioethics Research Center, Washington University School of Medicine, St. Louis, MO, USA

With funding from the National Institutes of Health, our team at Washington University School of Medicine developed an online toolkit, ConsentTools.org, to make consent processes in clinical trials more effective and efficient. It shares information, resources, brief videos, and tools to help clinical research professionals implement several evidence-informed consent practices. These include:

  • Using plain language
  • Using appropriate formatting
  • Assessing for understanding

Randomized controlled trials demonstrated that using these practices can increase participants’ understanding and appreciation of consent information.[1, 2] In this blog post, we explore how to adapt these practices when using eConsent in clinical trials.

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Clinical Research Nursing Conference– Understanding the role that nurses play in Clinical Research and Empowering them to become leaders in the field

Jennifer Goldfarb, MSN, RN, CCRP

We here at SOCRA are very excited for the relaunch of the Clinical Research Nursing Conference which will be offered virtually this November. The course faculty includes very experienced clinical research nursing professionals who will be bringing a wealth of knowledge and experience to the conference attendees. Take a look below for our Course Chair’s personal perspectives on Clinical Research Nursing – how she became a nurse, then clinical research professional and why she’s not only excited for this course, but also where the field is headed. As you’ll see below – this is an exciting time. This conference presents the opportunity to highlight the role that nurses play in Clinical Research, to celebrate this role, and to empower them to become leaders in the field.

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Operationalizing the Serious Adverse Event (SAE) Process at Clinical Research Sites

Operationalizing Serious Adverse Event Process

Tracy Popp, MBA
Previously: Director, Research Financial Operations Norton Healthcare, Inc.
Currently: Senior Director of Clinical Research, Tampa General Hospital

Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE) process beyond regulatory and clinical. Norton Healthcare, Inc. has developed policies and a workflow for operationalizing SAEs, including clinical, legal, billing, accounting, and budgeting capture. This article provides an overview of the way in which Norton Healthcare has done this as well as how other sites can also operationalize SAEs.

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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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Using Workflow Mapping to Improve the Recruitment Process in Clinical Trials

(Originally presented abstract at 2019 Annual Conference San Antonio)
Sara Sampaio MD, CCRP,*, Sepideh Saroukhani MD, MS, PhD candidate, Aryn Knight BS, CCRP, Jennifer L. Chambers RN, BSN, CCRC,
Emerson C. Perin MD, PhD, FA

Introduction

In this article, we describe the strategies and approaches developed at the Center for Clinical Research at Texas Heart Institute (THI) in Houston, Texas, to facilitate efficient participant recruitment for heart failure–related randomized controlled trials (RCTs). Randomized trials are typically complex in terms of the target population, protocol design, and intervention strategies — factors that can hinder the recruitment of a sufficient number of eligible participants. Thus, detailed upstream planning is crucial to guide recruitment efforts — especially in trials that focus on serious medical conditions such as heart failure — and a trained recruitment team is needed to execute protocol-specified tasks. Despite extensive literature on strategies for enhancing participant recruitment in research, little has been reported about the actual activities and experiences associated with recruitment and about the impact of organizational strategies on this work.

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Introducing Generation Z: Who Are They and How Will They Impact the Clinical Research Workplace?

Barbara van der Schalie, MS
Learning and Professional Development Manager  
Clinical Monitoring Research Program Directorate
Frederick National Laboratory for Cancer Research, Sponsored by the National Cancer Institute

Abstract: Generation Z, the postmillennials, are the latest addition to the extremely generationally-diverse American clinical research workplace. Their preferences for critical workplace parameters, including workplace engagement, communication, leadership approaches, and flexibility, differentiate them from even their most closely age-aligned colleagues, the millennials. This article describes the differences between and preferences of the generation and provides ways to optimize the integration of Generation Z into the current clinical research workplace.

Disclaimer: This project has been funded in whole or in part with federal funds from the National Cancer Institute, National Institutes of Health, under Contract No. HHSN261200800001E. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.

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