Development of EDC based on structural case report form
JIANG Zhi-wei
XIA Jie-lai
LI Chan-juan
WANG Ling
ZHANG Chun-mao
Abstract：At present,electronic data capture (EDC),which has increasingly attracted the attention of pharmaceutical enterprises,CROs and clinical researchers,has been applied to clinical trials of new drug gradual-ly. The reusability of eCRF design in different clinical trials is the key problems of EDC building. According to the characteristics of highly structural case report form in clinical trials,the automatic generation of database and inter-face will be realized by building generic database model and metadata repository of CRF and using the technology of XML. Also,the clinical data would be submitted and retrieved. The electronic data capture would be implemented by using the strategy based on the structural case report form.
Keywords：electronic data capturecase report formgeneric database modelentity-attribute-valueexten-sible markup languagemetadata repository
Publication Date：2009-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2199-2204 )