T/CI 010-2023 Establishing standard data sets for epilepsy diagnosis and treatment of traditional Chinese and Western medicine

Scope

Scope: This document specifies the metadata attributes of the standard data sets supporting the diagnosis and treatment of epilepsy in both traditional Chinese and Western medicine. This document is applicable to the collection, storage, sharing, and development of information systems for standard data sets of epilepsy research case histories in both traditional Chinese and Western medicine, as well as serving as a reference for epilepsy patients and their families during medical consultations. Main technical content: 3. Terms and definitions The following terms and definitions defined in WS 370-2022 and WS 445-2014 apply to this document. 3.1 Electronic medical records Electronic medical records (EMRs) are digital information generated by medical institution information systems during medical activities, including text, symbols, charts, graphics, data, and images, which can be stored, managed, transmitted, and reproduced. They constitute a form of medical recordkeeping. [WS/T 445.1-2014, Definition 3.1.1] 3.2 Case report forms Case report forms (CRFs) are documents designed according to clinical trial protocols to record data on each subject during the trial process. The data in CRFs come from original documents and must be consistent with them. Any observations or examination results during the trial should be recorded promptly, accurately, completely, standardly, and truthfully in the medical records and correctly filled out in the CRFs. Any modifications should not be made arbitrarily. If corrections are necessary due to errors, the original records must remain clear and legible, and the person making the corrections must sign their name and date. [FGWJ-2003-10254, Guidelines for Quality Management of Drug Clinical Trials (Ministry of Health Order No. 3), Chapter 8: Records and Reports] 3.3 Electronic data capture Electronic data capture (EDC) is a computer network-based technology for collecting clinical trial data. It directly collects and

Development Information

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