Approach to CDISC SDTM Implementation for Clinical Trials Data Submission
10.11842/wst.2015.02.001
- VernacularTitle:中医临床研究中实现CDISC SDTM标准的方法
- Author:
Yanke AI
;
Liyun HE
;
Tiancai WEN
;
Dongning WU
;
Baoyan LIU
- Publication Type:Journal Article
- Keywords:
Clinical research;
Study Data Tabulation Model;
data submission;
method
- From:
World Science and Technology-Modernization of Traditional Chinese Medicine
2015;(2):301-305
- CountryChina
- Language:Chinese
-
Abstract:
This study was aimed to discuss the ways of converting clinical data entered in the Case Report Form (CRF) to Study Data Tabulation Model (SDTM) database format in clinical research of traditional Chinese medicine (TCM). Currently, there were three approaches for implementing SDTM, which were the pure SDTM approach, submission-only approach and database-only approach. This article compared and analyzed advantages and disadvantages of three approaches and introduced experiences of the Clinical Evaluation Center of China Academy of Chinese Medical Sciences using database-only approach for SDTM implementation. The results showed that pure SDTM approach can maximally embrace SDTM standards. However, the current process and software system should be modified. Therefore, it was time-consuming and expensive. The submission-only approach was the most economic way in the application of SDTM standards. However, the data quality and traceability may not be guaranteed. The database-only approach built the study database based on the SDTM standard by writing transformed program before data entry while the data collection system was not SDTM-compatible. It was concluded that database-only approach for implementation SDTM was a suitable and practical way to TCM clinical research.
