Through a systematic review of the origin and 40 years of development of Traditional Chinese Medicine(TCM) big data knowledge engineering, we clariffy the major events and research achievements in each stage of the research, expound the ideas and methods of real world TCM clinical study based on medical records, emphasize the importance of transforming from data driven mode to data and knowledge driven mode to promote the innovation of the real world TCM clinical study model, and argue that the basis of model transformation and innovation is to reconstruct the knowledge attributes of TCM clinical case data base, make tacit knowledge explicit, realize full expression of knowledge, and build a TCM clinical case knowledge base.Taking case data knowledge, knowledge coding and knowledge mapping as examples, we highlight the key technologies and core links of TCM big data knowledge engineering, and fully confirm that big data knowledge engineering is the only way for real world TCM clinical study.Under the guidance of the national high-quality development strategy of TCM, with the goal of cultivating new quality productivity and forming a new business form of clinical research of TCM with new development concepts, we will build a big data knowledge engineering technology platform and a warehouse of TCM clinical knowledge, provide a technical platform and knowledge resources for carrying out large-scale model research in the field of TCM, and promote the clinical intelligence and high-quality development of TCM.

big data knowledge engineering  /  real world clinical research of traditional Chinese medicine  /  data knowledgeization  /  knowledge encoding