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


Recherche Transformation Rapide LLC

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



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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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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Building a Quality Assurance Program for Investigator-initiated Trials

Abby Statler, MPH, MA, CCRP
Research Regulatory Quality Assurance Coordinator
Cleveland Clinic Cancer Institute

Two clinical researchers analyzing information on a computer

Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past nine years, the program has become an integral part of the Institute’s research department, supporting the growth of IITs while improving the proficiency of regulatory operations. This article describes the program’s objectives and discusses the operational strategies employed to achieve these goals. Other clinical research sites are encouraged to consider how components of the Cleveland Clinic Cancer Institute’s QA program may be adapted to meet the needs of their organizations.


The research sponsored by Cleveland Clinic investigators supports the Foundation’s innovation initiatives, making it a top priority for the Institute’s leadership team. Thus, the development and implementation of the Cleveland Clinic Taussig Cancer Institute’s QA program was motivated by the organization’s commitment to effectively oversee the conduct of IITs. Launched in 2008, the Cancer Institute’s QA program was the first of its kind, specifically focusing on providing operational support for investigator-initiated trials.

Before the department was implemented, investigator-initiated trials had few operational resources, protocols required multiple revisions, Investigational New Drug Applications were submitted inconsistently to the U.S. Food and Drug Administration (FDA), and processes for effective essential regulatory documentation management had not been established. To date, the QA program has grown from one to five members, which has enabled the department to cohesively support the IIT profile while also improve the operations of industry-sponsored and cooperative group trials. In this article, I will outline the essential components of a QA program, discuss the challenges that our department faced during the program’s development, and highlight how the Institute’s commitment to quality has enhanced the Cancer Center’s conduct and initiation of clinical trials.

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Quality by Design for Clinical Trials

Vatché Bartekian
President, Vantage BioTrials, Inc.

Abstract: Quality by design for clinical trials comprises an independent entity responsible for quality standards and an integrated system where each person is accountable for quality. This article explores myths about quality and provides a general overview of the principles and philosophy of quality by design. Quality issues normally encountered at clinical research sites and contract research organizations as well as practical ways to build quality into a research program in order to prevent issues are highlighted. The Plan-Do-Check-Act cycle and its tie-in with risk-based monitoring are described.

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