Clinical Data Management
The clinical data management plays a key role in the setup and conduct of a clinical trial. The data collected during a clinical trial forms the basis of subsequent safety and efficacy analysis which in turn drive decision making on product development in the pharmaceutical industry.
Course Goal
The course focuses upon:
- Performing clinical data management tasks
- Spatial orientation of clinical research data management
Curriculum
- Good clinical practice & other regulatory guidelines
- Protocol & CRF designing
- Clinical data management
- Data capture method
- Data entry
- External data loading
- Data validation
- Query management
- Data storage & archival
- Quality systems, SOPs
- Regulations & guidelines for CDM
- Safety data management
- Quality systems, SOPs
- Statistical analysis & reporting
- Data Management Systems & Tools
- Documentation & Document Management System
- Medical coding and medical dictionaries
- Practical clinical data management system
- Study set-up
- GLIBS
- Data Entry
- Data Validation
- Query Management
- Database lock