Certificate in Trial Data Strategies
-- ViewingNowThe Certificate in Trial Data Strategies is a comprehensive course designed to meet the growing industry demand for professionals with expertise in clinical trial data management. This program emphasizes the importance of robust data strategies in ensuring successful trial outcomes, regulatory compliance, and informed decision-making.
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โข Introduction to Trial Data Strategies: Understanding the basics of trial data management, including data collection, validation, and reporting.
โข Data Standards and Regulations: Overview of data standards and regulations in clinical trials, including FDA 21 CFR Part 11, HIPAA, and ICH GCP.
โข Data Management Planning: Best practices for creating a data management plan, including data definitions, data validation, and data security.
โข Data Collection Methods: Comparison of different data collection methods, including paper case report forms (CRFs), electronic CRFs (eCRFs), and remote data entry.
โข Data Cleaning and Quality Control: Strategies for identifying and correcting data errors, including data query management and data quality metrics.
โข Data Analysis and Reporting: Techniques for analyzing and reporting trial data, including statistical analysis plans and clinical study reports.
โข Data Integration and Interoperability: Overview of data integration and interoperability in clinical trials, including data standards and APIs.
โข Data Security and Privacy: Best practices for protecting trial data, including data encryption, access controls, and breach notification.
โข Data Archiving and Retention: Guidelines for archiving and retaining trial data, including data backup and disaster recovery.
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