Temple University 3 credits QARA
This course examines the federal regulatory requirements and processes necessary to conduct valid drug trials on human volunteers. Emphasis is placed on managing the clinical drug study and auditing its processes and generated data. The course also addresses ethical issues and volunteer informed consent. Note: This course fulfills the GxP requirement for the M.S. in RA and QA students and for the Drug Development Certificate. It is required for the Certificate in Clinical Trial Management.
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