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Sarah Fowler-Dixon, PhD, CIP currently works with the human research protection program at Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, guidelines, reporting, and training for researchers and staff. She often works with state and federal authorities such as the NIH and FDA. She has provided consultation regarding ethical, federal, state, and institutional requirements in the design and execution of projects. Dr. Fowler-Dixon teaches research ethics and regulatory affairs, the fundamentals of clinical research management and mentors honors students in the Clinical Research Management program.
The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was pa ...
The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the t ...