With the increasing improvement of real-world evidence as a research system and guideline specification for pre-market registration and post-market regulatory decision support of clinically urgent drug and mechanical products, identifying an approach to ensure the high quality and standards of real-world data and establishing a basis for the generation of real-world evidence is receiving increasing attention and concern from regulatory authorities. Based on the experience of Boao hope city real-world data research pattern and ophthalmic data platform construction, this paper discussed the "source data-database-evidence chain" generation process, data management, and data governance in real-world study from the special features and necessity of multiple sources and heterogeneity of data, multiple research designs, and standardized regulatory requirements, and provided references for further construction of comprehensive research data platforms in the future.
