Case Report Form (CRF) is a structured and standardized document used for systematic data collection during a clinical trial. It provides a template for recording participant information, study outcomes, and other essential data points. CRFs are designed to maintain data accuracy and consistency, ensuring that the information collected is reliable and can be analyzed for research and regulatory purposes.
Definitions
ICH E6
A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject [1].
See also
Links to this page
- Source documents (← links)
- Case Report Form (redirect page) (← links)
- Essential documents (← links)
- Clinical data management (← links)
- Abbreviations (← links)
- Glossary:Case Report Form (redirect page) (← links)
- Certified copy (← links)
References
- ↑ ICH website, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf