CDISC standard-based electronic archiving of clinical trials

Methods of Information in Medicine

Volumn 48, Issue 5, 2009, Pages 408-413

  Kuchinke, W ^a   Aerts, J ^b   Semler, S C ^c   Ohmann, C ^a  

^a HEINRICH HEINE UNIVERSITY   (Germany)

^b XML4 Pharma   (Germany)

^c Telematics Platform for Medical Research Networks (TMF EV)   (Germany)

Author keywords

Archive; CDISC; Clinical trials; Data management; GCP; Good Clinical Practice; ODM; SDTM; Trial master file

Indexed keywords

ARTICLE; CLINICAL TRIAL; COMPUTER NETWORK; COMPUTER SECURITY; DATA BASE; DOCUMENTATION; GERMANY; HUMAN; INFORMATION CENTER; INFORMATION PROCESSING; INFORMATION RETRIEVAL; MATHEMATICAL COMPUTING; MEDICAL INFORMATICS; MEDICAL RECORD; QUALITY CONTROL; STANDARD; STATISTICS;

ARCHIVES; BENCHMARKING; CLINICAL TRIALS AS TOPIC; COMPUTER COMMUNICATION NETWORKS; COMPUTER SECURITY; DATA COLLECTION; DATABASE MANAGEMENT SYSTEMS; DOCUMENTATION; GERMANY; HUMANS; INFORMATION STORAGE AND RETRIEVAL; MATHEMATICAL COMPUTING; MEDICAL INFORMATICS COMPUTING; MEDICAL RECORDS SYSTEMS, COMPUTERIZED; REFERENCE STANDARDS;

EID: 76649095365     PISSN: 00261270     EISSN: None     Source Type: Journal    
DOI: 10.3414/ME9236     Document Type: Conference Paper

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