Retrospective database study is an important type of real world study that employ observational designs, which has received wide attention. However, misunderstandings and inappropriate conduct of retrospective database studies are very common. We systematically introduced the concept, features and applications of retrospective database study, as well as discussed the methods to plan a retrospective database study and how to develop a research database. This article is expected to offer guidance for the quality production and appropriate use of retrospective database study.
As an important source for real-world data, existing health and medical data have gained wide attentions recently. As the first part of the serial technical guidance for real-world data and studies, this report introduced the concepts, features and potential applications of existing medical and health data, proposed recommendations for planning and developing a research database using existing health and medical data, and developed essential indicators for assessing the quality of such research databases. The technical guidance may standardize and improve the development of research database using existing health and medical data in China.