This specialization on Clinical Trials Operations is designed for individuals and teams involved in running or interacting with clinical trials. Over four courses, learners will develop the insights and skills necessary for designing, managing, and monitoring clinical trials, as well as analyzing, documenting, and communicating results. The program covers best practices in ethics, safety, participant recruitment, regulatory compliance, and reporting standards. The core principles and skills acquired in this specialization will form a solid foundation for a successful career in the field of clinical trials operations.
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This specialization comprises four courses, covering the design, management, monitoring, and analysis of clinical trials, with a focus on ethical and regulatory considerations.
Evaluate and select clinical trial designs
Implement bias control measures
Randomize participants into groups
Define clinical trial outcomes
Collect and manage clinical trials data
Assemble and share clinical trials data
Conduct statistical performance monitoring
Perform quality assurance for clinical trials
Detect and respond to protocol events
Recognize and respond to misconduct
Safeguard participant safety and trial integrity
Develop and maintain study documents
Calculate clinical trial sample size
Monitor clinical trial performance
Analyze results from clinical trials
Communicate results from clinical trials
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