Global Certificate in Drug Development Clinical Trial Monitoring
-- ViewingNowThe Global Certificate in Drug Development Clinical Trial Monitoring is a comprehensive course designed to equip learners with the essential skills required to thrive in the rapidly evolving field of clinical research. This course is critical for those seeking to advance their careers in drug development, as it provides in-depth knowledge of clinical trial monitoring and management.
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โข Introduction to Clinical Trial Monitoring: Roles, responsibilities, and goals of clinical trial monitoring
โข Regulatory Landscape: FDA, EMA, ICH guidelines and regulations for clinical trial monitoring
โข Source Data Verification (SDV): Techniques, challenges, and best practices
โข Data Management Planning: Database design, data validation, and data quality assurance
โข Site Management and Training: Site selection, initiation, monitoring, and close-out
โข Adverse Event Reporting: Safety monitoring, SAE reporting, and follow-up
โข Quality Assurance and Quality Control: Audit, inspection, and quality metrics
โข Risk-Based Monitoring: Risk identification, assessment, and mitigation
โข Management of Clinical Trial Data: Data backup, recovery, and archive
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