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pubmed-article:19621114pubmed:abstractTextOur objectives were to develop, based on the analysis of archived clinical trial documents and data and on the requirements of GCP-compliant electronic archiving, a concept for legally secure and technically feasible archiving of the entire clinical trial, including the essential documents of the trial master file and the study database.lld:pubmed
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pubmed-article:19621114pubmed:year2009lld:pubmed
pubmed-article:19621114pubmed:articleTitleCDISC standard-based electronic archiving of clinical trials.lld:pubmed
pubmed-article:19621114pubmed:affiliationCoordination Centre for Clinical Trials (KKS Düsseldorf), Heinrich Heine University, Medical Faculty, 40225 Duesseldorf, Germany. kuchinke@med.uni-duesseldorf.delld:pubmed
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