Digitale Archivierung papierbasierter Krankenakten von Studienpatienten - Eckpunktepapier des KKSN, der GMDS und der TMF unter Mitwirkung des BfArM und der Landesüberwachungsbehörde Nordrhein-Westfalen.

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 care. However, at present it is unclear under which circumstances the patient records of patients taking part in clinical trials can be destroyed after digitization. Paper-based original records may only be destroyed if their digital copies are recognized as source documents by both sponsors and authorities. The authors believe that this recognition should be possible, as long as the scanned paper-based records fulfill the requirements for certified copies according to the Note for Guidance CPMP/ICH/135/95 (ICH-GCP). This requires that, based on the applied rules, it can be proven at any time that the existing digitization process is clearly regulated, and the resulting quality is regularly controlled and sufficiently high. The objective of this key issues paper is to present the manner in which the existing regulatory guidelines can be implemented to allow the digitized patient records being recognized as source documents. An English version of this article will be published in “Clinical Investigation” (Future Science) [1]. [ABSTRACT FROM AUTHOR]