Track 40: Medical Data Management and Biostatistics

Overview: Medical Data Management and Biostatistics

Medical Data Management and Biostatistics are critical components of clinical and medical research, ensuring that data collected from studies are accurate, reliable, and statistically valid. Data management involves the design, collection, validation, storage, and protection of clinical trial data, using standardized systems like electronic data capture (EDC) and clinical trial management systems (CTMS). It ensures data integrity, compliance with regulatory standards (e.g., GCP, FDA 21 CFR Part 11), and readiness for analysis. Biostatistics applies statistical reasoning and methods to analyze and interpret medical data, supporting study design, determining sample sizes, assessing outcomes, and validating hypotheses. It plays a crucial role in decision-making at every stage of clinical trials, from protocol development to regulatory submission.

Key Sub-Topics in Medical Data Management and Biostatistics:

Electronic Data Capture (EDC) Systems · Case Report Form (CRF) Design · Data Cleaning and Validation · Database Locking · Statistical Study Design · Sample Size Calculation · Hypothesis Testing · Survival Analysis · Multivariate Analysis · Statistical Modeling · Interim and Final Data Analysis · Data Visualization and Reporting · Good Clinical Data Management Practices (GCDMP) · Regulatory Compliance in Data Handling · Real-Time Data Monitoring