CRPV108 Clinical Data Management and Data Integrity (QC&QA)

Clinical data management (CDM) is the process of collecting, storing, and managing clinical trial data in a structured manner. CDM is a critical component of clinical trials and involves the accurate and complete capture of all data related to study participants, including demographics, medical history, adverse events, and treatment outcomes.

Data integrity is a key aspect of CDM and involves the maintenance of the accuracy, reliability, and consistency of data throughout the clinical trial. Quality assurance (QA) and quality control (QC) are critical components of data integrity and ensure that data is accurate, complete, and consistent.

The course introduces the students to the basics of clinical research and drug safety Data Management with emphasis on practical and regulatory aspects of clinical data entry and Electronic Data Capture (EDC) systems. Students will have a practical understanding of the clinical data cycle and data management in the clinical study and data quality assurance. The clinical trial database, EDC systems, MedDRA, and Drug Dictionary will be discussed in detail.

Learning Points:

• Overview of Data Management in Clinical Research
• Regulatory Framework and Data collection flow
• The Clinical Trial Database and EDC system
• Serious Adverse Events in Clinical Trials Safety Database
• MedDRA and Drug Coding
• Data Quality Assurance
• CRF/eCRF development