pubmed:abstractText |
Our 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.
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pubmed:affiliation |
Coordination Centre for Clinical Trials (KKS Düsseldorf), Heinrich Heine University, Medical Faculty, 40225 Duesseldorf, Germany. kuchinke@med.uni-duesseldorf.de
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