The Problems and Solutions in the Design and Record of TCM Clinical Research Case Report Form
- VernacularTitle:中医药临床研究病例报告表设计和记录的存在问题及解决策略
- Author:
Fang HAN
1
;
Kegang CAO
;
Ying GAO
;
Baoli LIU
;
Tiantian ZHOU
;
Jing HU
Author Information
- Publication Type:Journal Article
- Keywords: Traditional Chinese Medicine; Clinical research; Case report form; Design; Record
- From: World Science and Technology-Modernization of Traditional Chinese Medicine 2025;27(2):533-538
- CountryChina
- Language:Chinese
- Abstract: Case report form(CRF)is an important tool to obtain clinical research data.Scientifically designed and properly recorded CRF is of great significance to improve the quality of clinical research.The author summarized the common problems existing in the design and recording of CRF in traditional Chinese medicine(TCM)clinical studies,including:①Delayed design time point.②Unstandardized CRF design,recording and modification.③Imperfect records of combined medication/therapy.④Insufficient quantification of syndrome efficacy indicators and objectification of tongue and pulse.⑤ Insufficient protection of subjects' privacy.⑥ Unstandardized records of adverse events.Accordingly,this paper discusses some solutions to provide reference for other TCM researchers,including:①Advance CRF design time.②Standardize CRF design,recording and modification.③Design drug combinations/therapies according to Clinical Data Acquisition Standards Harmonization(CDASH).④Standardization of syndrome and tongue and pulse.⑤Use of subject identification codes to protect privacy.⑥AE records should vary from study to study.
