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