CLiREN-LMS
Protocol Translation and CRF Design

Visit Schedules and Longitudinal Data Collection

Learning Outcomes

30-45 minutes Foundational Step 2 of 7
Outcomes

Learning Outcomes

2 / 7
  • 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.