The most commonly performed clinical trials evaluate drug candidates, medical devices, biologics and other interventions in patients in strictly controlled scientific settings and are required for regulatory approval for commercial use of the therapies. Trials may be designed to assess the safety and efficacy of an experimental therapy to determine whether the new intervention is better than the standard therapy or to compare the efficacy to other marketed interventions. Trial objectives and design are typically documented in the clinical trial protocol. This course is organized to explore the process of clinical trial design in a sequential manner and provide an overview of the different types of trial designs commonly used today. Participants will ultimately design a sample protocol and informed consent procedure.
This course will be beneficial to those who are new to clinical research or those with experience in clinical research but with limited exposure to study protocol and trial design. Clinical research associates, compliance and quality team members, study coordinators and investigators will also benefit.
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