Global Certificate in Clinical Trial Design and Planning
-- ViewingNowThe Global Certificate in Clinical Trial Design and Planning is a comprehensive course that equips learners with the essential skills needed for success in clinical research. This program emphasizes the importance of proper clinical trial design and planning, which are critical components in the development of new medical treatments and therapies.
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โข Introduction to Clinical Trials: Defining clinical trials, phases of clinical trials, and the importance of clinical trial design and planning.
โข Regulatory Frameworks: An overview of global regulations, ethical considerations, and compliance requirements for clinical trial design and planning.
โข Study Objectives and Endpoints: Defining study objectives, identifying appropriate endpoints, and understanding the role of primary and secondary endpoints.
โข Study Population and Sampling: Identifying the target population, sampling strategies, and considerations for subject recruitment and retention.
โข Study Design and Methodology: Comparing different study designs, selecting the appropriate design, and understanding the importance of randomization, blinding, and placebo control.
โข Data Management and Monitoring: Establishing data management plans, implementing data monitoring committees, and ensuring data quality.
โข Statistical Analysis Planning: Designing statistical analysis plans, selecting appropriate statistical methods, and understanding the role of power calculations and sample size estimation.
โข Budgeting and Contracting: Preparing budgets, negotiating contracts, and managing financial aspects of clinical trials.
โข Risk-based Quality Management: Implementing risk-based quality management systems, identifying and mitigating risks, and ensuring GCP compliance.
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