Demonstrative Documents in Clinical Research Compliance
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A study’s protocol must be followed in order to maintain compliance. In order to demonstrate compliance, the study team should implement dynamic documentation that clearly and concisely tells a subject's story of participation in the clinical study. By prioritizing adherence to the protocol and documentation of the subject's experience, the study team will successfully demonstrate compliance and mitigate risk.
OBJECTIVE: Discuss document creation and maintenance to support procedures described in the IRB-approved protocol.
Amber Ashley Parker, BA, CCRP
Research QA Monitor, Office of Research Compliance
Children's Hospital of Philadelphia
Amber is currently a Research Quality Assurance Monitor in the Office of Research Compliance (ORC) at the Children’s Hospital of Philadelphia (CHOP). Amber has over a decade of experience in the business and conduct of clinical research as a public relations representative, clinical research coordinator, research associate, and investigator. Her education and professional experience allows her to successfully consult with study teams and various organizations on research initiatives. Amber is currently pursuing a Master’s of Bioethics at the Perelman School of Medicine at the University of Pennsylvania and holds a Bachelors of Arts in Health & Societies, with a concentration in Bioethics & Society from University of Pennsylvania. She also completed a University minor in Health Care Management and Biological Basis of Behavior from the Wharton School of Business and the College of Arts & Sciences at the University of Pennsylvania. Amber is a Certified Clinical Research Professional, by the Society of Clinical Research Associates (SOCRA), and is also an active member of the Regulatory Affairs Professional Society (RAPS).