Clinical Data Management Fundamentals
Course duration: 2 weeks
Clinical Data Management Fundamentals
This short course provides participants with a comprehensive understanding of the fundamentals of clinical data management (CDM). Participants will learn the key principles and best practices for effectively managing clinical trial data, ensuring data integrity, and regulatory compliance. The course covers essential topics such as data collection, database design, data validation, quality control, and data cleaning. Through interactive lectures, case studies, and practical exercises, participants will gain hands-on experience in managing clinical data throughout the data lifecycle.
Course Outline
- Introduction to Clinical Data Management
- Regulatory Guidelines and Standards
- Data Collection and Case Report Form (CRF) Design
- Database Design and Data Entry
- Data Validation and Quality Control
- Data Cleaning and Query Management
- Data Reconciliation and Database Lock
- Data Management Plans and Standard Operating Procedures (SOPs)
- Electronic Data Capture (EDC) Systems
- Case Studies and Practical Exercises
Course Prerequisites
- Basic understanding of clinical research processes and terminology
- Familiarity with basic computer skills and data entry
Who Should Attend
- Clinical research professionals involved in data management activities
- Data managers, research coordinators, and data entry personnel in clinical research organizations
- Students and professionals seeking to enhance their skills in clinical data management
Course Benefits
- Gain a comprehensive understanding of clinical data management principles and practices
- Learn essential techniques for ensuring data integrity and quality in clinical trials
- Familiarize yourself with industry-standard tools and technologies for data management
- Acquire practical skills through hands-on exercises and case studies
- Enhance your career prospects in the field of clinical data management
