Clinical Data Management (CDM)
Learn to ensure data accuracy, completeness, and consistency.
About the course
Welcome to our comprehensive Clinical Data Management (CDM) course, designed to equip you with the skills and knowledge needed to excel in managing clinical data for research and development. This program covers the entire CDM lifecycle, from study setup and data collection to data cleaning, validation, and reporting. Learn industry best practices and regulatory requirements to ensure the integrity and quality of clinical trial data.
Course content
- Overview of Clinical Trials:
- Phases of clinical trials and their objectives.
- The role of data management in clinical research.
- CDM Fundamentals:
- Importance of data quality and integrity.
- Roles and responsibilities of a clinical data manager.
- Regulatory Landscape:
- Introduction to Good Clinical Practice (GCP).
- Understanding regulatory requirements for data management.
- Protocol Review and CRF Design:
- Understanding clinical trial protocols.
- Designing Case Report Forms (CRFs) and eCRFs.
- Database Design and Development:
- Creating clinical databases.
- Using EDC (Electronic Data Capture) systems.
- Data Entry and Query Management:
- Data entry procedures and best practices.
- Handling data queries and discrepancies.
- Data Validation Techniques:
- Logic checks, range checks, and consistency checks.
- Identifying and resolving data discrepancies.
- Medical Coding and Terminology:
- Using MedDRA and WHO Drug dictionaries.
- Coding adverse events and medications.
- Data Quality Control:
- Implementing data quality plans.
- Conducting data audits and reviews.
- Statistical Concepts and Data Analysis:
- Basic statistical concepts for data analysis.
- Generating data listings and reports.
- Data Reporting and Submission:
- Preparing data for regulatory submissions.
- Understanding CDISC standards (CDASH, SDTM, ADaM).
- Safety Data Management:
- Handling serious adverse events (SAEs) and safety data.
- Reporting safety data to regulatory authorities.
- Introduction to EDC Systems:
- Overview of popular EDC platforms (e.g., Medidata Rave, Oracle Clinical).
- Navigating and using EDC systems.
- Data Integration and Interoperability:
- Integrating data from different sources.
- Ensuring data interoperability.
- Data Security and Privacy:
- Protecting patient data and ensuring compliance with privacy regulations.
- Standard Operating Procedures (SOPs):
- Developing and implementing SOPs for CDM.
- Ensuring compliance with internal and external regulations.
- Audits and Inspections:
- Preparing for and conducting data audits and inspections.
- Addressing audit findings and corrective actions.
- Risk Management:
- Identifying and mitigating risks in data management
- Real-World Case Studies:
- Analyzing and resolving data management challenges.
- Applying learned concepts to practical scenarios.
- Project Work:
- Designing and managing a simulated clinical trial database.
- Presenting data management findings.
