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当前,国际上日益重视临床试验或临床研究中电子病例报告表(e-CRF)的利用。就中医临床科研信息一体化采集系统(中医结构化电子病历)与中医e-CRF能否相结合,以及二者相结合的必要性、可行性、具体方法和模式、其中的关键环节,以及二者结合的价值、优势和意义等问题进行了思考和探讨。初步认为,结构化电子病历与e-CRF二者的结合是必要和可行的,具有一定优势和重要意义。具体模式可在开发平台、术语和接口三个方面进行。同时,二者结合可能是未来将临床结构化电子病历引入临床观察研究的一种形式;而且,未来二者结合的模式将更适于大规模复杂干预的临床研究,为中医临床研究带来更多实用和便捷,必将拥有广泛的应用前景。
Currently, there is increasing international emphasis on the use of electronic case report forms (e-CRFs) in clinical trials or clinical studies. On the integration of TCM clinical research information collection system (TCM structured electronic medical records) and Chinese medicine e-CRF, and the necessity, feasibility, specific methods and modes of combination of the two, one of the key links, as well as two The combination of value, advantages and significance of issues such as thinking and discussion. It is initially believed that the combination of structured electronic medical record and e-CRF is necessary and feasible, which has certain advantages and significance. The specific model in the development platform, terms and interfaces in three areas. At the same time, the combination of the two may be a form of introducing clinical structured electronic medical records into clinical observation in the future. Moreover, the combination of the two will be more suitable for clinical research of large-scale and complex intervention in the future, bringing more advantages to TCM clinical research More practical and convenient, will have a wide range of applications.