Executive Development in Trial Data Management
-- ViewingNowThe Executive Development in Trial Data Management certificate course is a comprehensive program designed to equip learners with the essential skills necessary for success in trial data management roles. This course is of paramount importance in the pharmaceutical and biotechnology industries, where effective data management is crucial for regulatory compliance and successful clinical trials.
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โข Introduction to Trial Data Management: Understanding the basics of data management in clinical trials, including data collection, cleaning, and validation.
โข Data Management Planning: Learning to develop data management plans, including data definitions, data flow diagrams, and data validation plans.
โข Data Collection Methods: Exploring various data collection methods, such as electronic data capture (EDC), paper case report forms (CRFs), and remote data entry.
โข Data Cleaning Techniques: Mastering data cleaning techniques, including data editing, data querying, and data reconciliation.
โข Data Validation Strategies: Understanding data validation strategies, including data validation rules, data validation checks, and data validation reports.
โข Data Security and Privacy: Learning about data security and privacy regulations, such as HIPAA, GDPR, and 21 CFR Part 11, and how to implement appropriate data security measures.
โข Data Management Systems: Exploring different data management systems, including EDC systems, clinical trial management systems (CTMS), and clinical data management systems (CDMS).
โข Data Integration and Reporting: Mastering data integration and reporting techniques, including data aggregation, data visualization, and data reporting.
โข Quality Control and Quality Assurance: Understanding quality control and quality assurance concepts, including risk-based monitoring, quality management plans, and quality metrics.
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