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| Delia Y. Wolf, Harvard Medical School |
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| Dr. Delia Wolf is the Director of the Partners Human Research Quality Improvement Program (QI Program) and an Assistant Professor of Radiology at Harvard Medical School. She has successfully designed and implemented the QI Program that oversees about 4,000 IRB-approved studies within Partners institutions, which include Massachusetts General Hospital and Brigham and Women’s Hospital. She served as an IRB chair between 1999 and 2005. Besides her medical degree, Dr. Wolf holds a Juris Doctor degree and a master’s degree in clinical investigation. She also completed a fellowship in Medical Ethics in 2001. As a former clinical researcher, IRB chair and QI Program Director for more than six years, Dr. Wolf has extensive experience in conducting, organizing, developing, and overseeing the full spectrum of clinical research. Her research interests include quality improvement approaches in human research protection, as well as specific legal issues such as investigator and IRB liability in biomedical research.
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What a Quality Assurance Program can do to Facilitate Clinical Research and Development Process
Delia Y. Wolf, Harvard Medical School
The key to an efficient clinical research and development process is not only having a well-designed protocol, but also having a well-run clinical trial. As the majority of these clinical trials are conducted by investigators in an academic medical center, it is important to ensure that each participating investigator is well-informed about both scientific and regulatory requirements. In fact, a recent FDA report found that investigator noncompliance accounted for more than 70% of the deficiencies noted in the agency’s audit findings. One way to improve investigators’ understanding of and compliance with clinical research regulations and guidelines is implementing an effective quality assurance (QA) program that aims to improve investigator compliance with federal regulations, Good Clinical Practice (GCP) guidelines, and institutional requirements by providing on-site audit and assisting with investigator self-assessment.
The morning presentation will provide an overview of two practical QA approaches, namely onsite audit and investigator self-assessment, as well as their effectiveness in measuring compliance. The afternoon workshop will focus on a step–by-step guide to conducting an onsite audit and assisting investigators with conducting a self-assessment. Common findings of regulatory non-compliance in investigator-initiated study, as well as industry sponsored/CRO managed study will be covered. Practical tips on how to identify and avoid potential violations throughout clinical trials will also be discussed.
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