Global Certificate in Clinical Trial Management: Trial Coordination
-- ViewingNowThe Global Certificate in Clinical Trial Management: Trial Coordination is a comprehensive course, designed to empower learners with the necessary skills to thrive in clinical research. This certificate course emphasizes the importance of trial coordination, a critical component in the conduction of clinical trials, ensuring data integrity, and compliance with regulatory standards.
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⢠Trial Design and Protocol Development: Understanding the fundamentals of trial design, creating a protocol, and ensuring it meets regulatory requirements.
⢠Site Selection and Qualification: Identifying, assessing, and selecting suitable clinical trial sites and investigators.
⢠Budgeting and Contracting: Developing and managing budgets, contracts, and financial agreements with trial sites and vendors.
⢠Regulatory Affairs and Ethics: Navigating regulatory submissions, ethical approvals, and maintaining compliance throughout the trial.
⢠Project Management: Implementing project management strategies, tools, and best practices for successful trial coordination.
⢠Study Startup and Initiation: Executing site activation, training, and study initiation activities.
⢠Data Management: Overseeing data collection, data entry, data validation, and database management.
⢠Clinical Trial Monitoring: Coordinating on-site and remote monitoring activities to ensure data quality and patient safety.
⢠Quality Management and Quality Control: Implementing quality management systems and conducting quality control checks to ensure trial integrity.
⢠Clinical Trial Reporting and Closeout: Managing clinical study report preparation, statistical analysis, and closeout activities.
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