Foundations of Clinical Research Data Management: Orientation
Learning Objectives
Learning Objectives
Learning Objectives
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.