Digitale Archivierung papierbasierter Krankenakten von Studienpatienten – Eckpunktepapier des KKSN, der GMDS und der TMF unter Mitwirkung des BfArM und der Landesüberwachungsbehörde Nordrhein-Westfalen [Digital archiving of paper-based patient records of clinical trial subjects – a key issues paper of KKSN, GMDS, and TMF in collaboration with the Federal Institute for Drugs and Medical Devices (BfArM) and the Health Authority Northrhine-Westphalia]

Digitale Archivierung papierbasierter Krankenakten von Studienpatienten – Eckpunktepapier des KKSN, der GMDS und der TMF unter Mitwirkung des BfArM und der Landesüberwachungsbehörde Nordrhein-Westfalen [Digital archiving of paper-based patient records of clinical trial subjects – a key issues paper of KKSN, GMDS, and TMF in collaboration with the Federal Institute for Drugs and Medical Devices (BfArM) and the Health Authority Northrhine-Westphalia]

[english] The management and maintenance of paper-based patient record archives involve high running costs. Therefore, many health care providers choose to digitize their paper records subsequently destroying the originals. By now, this is an established procedure for patient records from routine ca...

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Bibliographic Details
Main Authors: Kohl, Christian D., Bruns, Insa, Freudigmann, Mathias, Scharf, Guido, Schmücker, Paul, Schwarz, Gabriele, Semler, Sebastian C.
Format: Article
Language:deu
Published: German Medical Science GMS Publishing House 2013-04-01
Series:GMS Medizinische Informatik, Biometrie und Epidemiologie
Subjects:
GCP-compliant, certified copy, paper-based patient records, CPMP/ICH/135/95, source documents, clinical trials, Good Clinical Practice, digital archiving system, digitization
GCP-Compliance, beglaubigte Kopie, papierbasierte Patientenakten, CPMP/ICH/135/95, Quelldokumente, klinische Studien, Good Clinical Practice, digitales Archivsystem, Digitalisierung
Online Access:http://www.egms.de/static/en/journals/mibe/2013-9/mibe000138.shtml

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