Data Protection, Ethics, and Confidentiality
Learning Outcomes
Outcomes
2 / 6
Learning Outcomes
- Explain the purpose and scope of clinical research data management.
- Describe how clinical data management has evolved from paper-based systems to modern electronic and reproducible workflows.
- Discuss why high-quality data are essential for valid research findings, participant protection, regulatory compliance, and public trust.
- Identify the main phases of the clinical research lifecycle and explain the data management responsibilities attached to each phase.
- Describe the role of the clinical data manager within a multidisciplinary research team.
- Explain the characteristics of high-quality clinical research data.
- Describe how Good Clinical Practice, FAIR Data Principles, research ethics, and data protection requirements shape clinical data management.