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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Tools and Techniques for Effective Clinical Research Start-up at an Academic Medical Center

Michael Mapel, CCRP
Clinical Research Lead
UCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1

Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from study teams. Research sponsors often have difficulty understanding any process lacking in consistency and transparency and so start-up becomes a barrier to study enrollment. This article breaks down such barriers by advocating specific project management and communication tools and techniques that accelerate the study start-up process without sacrificing quality.

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How to Motivate and Retain Clinical Research Staff

Takisha Adair, Clinical Operations Manager, Covance

Abstract: Retaining staff is challenging for clinical research organizations. Motivating employees and engagement can help reduce staff turnover. Organizational leaders who desire to retain a talented workforce should tap into employee motivations and identify ways to incorporate these, where applicable, in employee retention efforts. This article highlights the key elements to motivate and engage research staff, especially millennials. Strategies that have worked well are highlighted from leading generational and change management experts.

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Utilization of Cancer Registrars in Clinical Research

Rossio Y. Rodriquez, HIM, CTR 
Director, Data Management 
Proton Collaborative Group

What is a Cancer Registrar?

A cancer registry is the information system designed for the collection, management, and analysis of data on a person’s diagnosis that contains etiology, diagnosis, treatment of cancer, and patient’s status for as long as the patient is alive. The information in the registry is entered by a cancer registrar.

The men and women in this job role are very dedicated, detail oriented, and passionate about their oncology role.  They utilize many skills in their everyday tasks. However, one important skill that cancer registrars use the most is critical thinking. This is vital when reviewing a patient’s medical chart and putting together their cancer history into one abstract that is later used for cancer statistics. The role of the cancer registrar has a tendency to be overlooked as they are not in the frontline when it comes to the patient’s cancer care.   

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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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Project Management: Introduction to Tools and Templates

By: Melissa Harris, MPA, CCRP
Director of Interventional Resources & Clinical Trials Unit
Pennington Biomedical Research Center at LSU

Abstract: Project management involves many complex components and moving parts. Prior to initiating a clinical trial, various types of project tools and templates can be used to successfully plan and execute a clinical trial. This article highlights tools that are readily available for project management, including Microsoft Excel, Access, Visio, Outlook, and SharePoint, as well as Web-based applications. Monitoring progress through various tracking mechanisms ensures successful clinical trial execution from recruitment through retention and follow-up.

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Budget Development and Negotiation for Investigative Sites

Budget Development and Negotiation for Investigative Sites

Author: Anna K. Rockich, MS, Pharm D, Director, General Surgery Research Program, University of Kentucky Medical Center

Abstract: Effective budget development and negotiation is critical for investigative sites. This article provides an overview of budget requirements for the conduct of a study, identifies common mistakes in developing budgets, and highlights how to effectively develop the budget and negotiate with the sponsor. Tools to assist in managing the budget on a daily basis are provided.

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