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KMID : 0391020070150010020
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Journal of Korean Society for Clinical Pharmacology and Therapeutics
2007 Volume.15 No. 1 p.20 ~ p.27
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International Standard in Electronic Clinical Trial
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Jeong Sun-Ok
Choi In-Young
Kim Suk-Il
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Abstract
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As clinical trial researchers and companies continue to partner, merge, outsource, and make submissions for marketing approvals, the needs for streamlined data exchange increases. One study estimates that the industry spends more than $156 million annually contract research organizations (CRO) to sponsors and from electronic data capture(EDC) providers or clinical laboratories to sponsors or CRO. Without the use of standards, the activities associated with clinical development require duplicating efforts and a lot of rework, which translates into more time and higher costs. It is in everyone’s best interest to improve patient safety and reduce costs by bringing new treatments to market as quickly as possible, so the value of standardization is readily apparent. In 1997, The Clinical Data Interchange Standards Consortium (CDISC) established worldwide industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. CDISC has developed six standards. We specific describes CDISC Submission Tabulation Data Model (SDTM) in clinical trial. Finally, our own regulation should be developed for streamlined data interchange as soon as possible.
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KEYWORD
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e-Clinical Trials, Electronic Data Collection, Standard, Clinical Data Interchange Standards Consortium (CDISC)
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