Protocol Translation and CRF Design: Orientation
Learning Objectives
Learning Objectives
Learning Objectives
Explain the role of the study protocol as the foundation for clinical research data collection.
Translate research objectives, outcomes, eligibility criteria, procedures, and visit schedules into structured data requirements.
Distinguish between primary and secondary outcomes and describe their importance for CRF design.
Develop a data collection matrix that maps variables to study visits and data sources.
Apply principles of good Case Report Form design for paper CRFs and electronic CRFs.
Design variable names, coding schemes, and data dictionaries that support analysis, interoperability, and long-term documentation.
Explain why CRF version control is essential for data consistency and regulatory traceability.
Identify common CRF design errors and propose practical prevention strategies.