Clinical Trials Operations

Johns Hopkins University

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.

  • Design and implement clinical trials
  • Collect, manage, and analyze data
  • Conduct trial monitoring and quality assurance
  • Recruit and retain clinical trial participants

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Clinical Trials Operations
Course Modules

This specialization comprises four courses, covering the design, management, monitoring, and analysis of clinical trials, with a focus on ethical and regulatory considerations.

Design and Conduct of Clinical Trials

Evaluate and select clinical trial designs

Implement bias control measures

Randomize participants into groups

Define clinical trial outcomes

Clinical Trials Data Management and Quality Assurance

Collect and manage clinical trials data

Assemble and share clinical trials data

Conduct statistical performance monitoring

Perform quality assurance for clinical trials

Clinical Trials Management and Advanced Operations

Detect and respond to protocol events

Recognize and respond to misconduct

Safeguard participant safety and trial integrity

Develop and maintain study documents

Clinical Trials Analysis, Monitoring, and Presentation

Calculate clinical trial sample size

Monitor clinical trial performance

Analyze results from clinical trials

Communicate results from clinical trials

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