Executive Development in Trial Data Management
-- viewing nowThe 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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Course Details
• Introduction to Trial Data Management: Understanding the basics of data management in clinical trials, including data collection, cleaning, and validation.
• Data Management Planning: Learning to develop data management plans, including data definitions, data flow diagrams, and data validation plans.
• Data Collection Methods: Exploring various data collection methods, such as electronic data capture (EDC), paper case report forms (CRFs), and remote data entry.
• Data Cleaning Techniques: Mastering data cleaning techniques, including data editing, data querying, and data reconciliation.
• Data Validation Strategies: Understanding data validation strategies, including data validation rules, data validation checks, and data validation reports.
• 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.
• Data Management Systems: Exploring different data management systems, including EDC systems, clinical trial management systems (CTMS), and clinical data management systems (CDMS).
• Data Integration and Reporting: Mastering data integration and reporting techniques, including data aggregation, data visualization, and data reporting.
• Quality Control and Quality Assurance: Understanding quality control and quality assurance concepts, including risk-based monitoring, quality management plans, and quality metrics.
Career Path
Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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