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[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 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 (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) .[german] Das Verwalten und Vorhalten von Archiven für papierbasierte Patientenakten verursacht hohe laufende Kosten. Viele Gesundheitsversorger sind daher dazu übergegangen, ihre Papierakten in einem Scan-Prozess zu digitalisieren und die Originalakten anschließend zu vernichten. Für die Patientenversorgung hat sich dieses Vorgehen bewährt.Zum gegenwärtigen Zeitpunkt ist jedoch unklar, unter welchen Voraussetzungen Krankenakten von Patienten, die an klinischen Studien teilnehmen, nach dem Digitalisieren vernichtet werden können. Die papierbasierten Originalakten können nur dann vernichtet werden, wenn deren digitale Kopien von Sponsoren und Behörden als Quelldokumente anerkannt werden. Eine solche Anerkennung sollte nach Auffassung der Autoren möglich sein, wenn die gescannten Papierakten die Anforderungen an beglaubigte Kopien entsprechend der Note for Guidance CPMP/ICH/135/95 (ICH-GCP) erfüllen. Dies setzt voraus, dass auf der Basis bestehender Regelungen jederzeit nachgewiesen werden kann, dass der Digitalisierungsprozess klar geregelt ist, dessen Ergebnisqualität regelmäßig überprüft wird und ausreichend hoch ist.Ziel dieses Eckpunktepapiers des Netzwerks der Koordinierungszentren für Klinische Studien (KKSN, ), der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS, ) und der TMF – Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V. () unter Mitwirkung des Bundesinstituts für Arzneimittel und Medizinprodukte (BfArM, ) und der Landesüberwachungsbehörde Nordrhein-Westfalen (Landeshauptstadt Düsseldorf, Gesundheitsamt, Zentrales Inspektorat für klinische Prüfstellen in Nordrhein-Westfalen) ist es daher, darzulegen, wie die bestehenden regulatorischen Vorgaben so umgesetzt werden können, dass digitalisierte Patientenakten als Quelldokumente anerkannt werden.

Background: Emergency care in Germany is in transition. Emergency departments (EDs) treat their patients based on symptoms and acuity. However, this perspective is not reflected in claims data. The aim of the AKTIN project was to establish an Emergency Department Data Registry as a data privacy-compliant infrastructure for the use of routine medical data., Methods: Data from the respective documentation systems are continuously transmitted to local data warehouses using a standardized interface. They are available for several applications such as internal reports but also multicentre studies, in compliance with data privacy regulations. Based on a 12-months period we evaluate the population with focus on acuity assessment (triage) and vital parameters in combination with presenting complaints., Results: For the period April 2018 to March 2019, 436,149 cases from 15 EDs were available. A triage level is documented in 86.0% of cases, and 70.5% were triaged within 10 min of arrival. Ten EDs collected a presenting complaint regularly (82.3%). The respective documentation of vital signs shows plausible patterns., Conclusions: The AKTIN registry provides an almost real-time insight into German EDs, regardless of the primary documentation system and health insurance claims data. The Federal Joint Committee's requirements are largely met. Standardized presenting complaints allow for symptom-based analyses as well as health surveillance., (© 2020. The Author(s).)

Registries and cohort studies play a central role in patient-oriented medical research, in particular in health services research. In order to increase the transparency about ongoing registries and cohort studies in Germany, and to promote communication and cooperation between the drivers in the field a so-called register portal should be established. Metadata are characteristics that are used to describe registries and cohort studies in the register portal. A limited set of characteristics, the core set, should correctly describe the projects on the one hand while reducing workload for data capture and data administration on the other hand. The core set consists of 26 data elements that had been defined in a Delphi-consensus process involving experts from the working group registries of the German Network for Health Services Research (DNVF) and the working group IT infrastructure and quality management of the Technology, Methods, and Infrastructure for Networked Medical Research (TMF). Transparent policies are required to guarantee traceability and reliability of the portal's services. Six so-called top-level-tasks and 37 use cases were defined in an interim report so far. The metadata have been agreed upon by most of the member associations of the DNVF. Metadata and rules of procedures are the starting point for the practical implementation of the register portal in the next future., (© Georg Thieme Verlag KG Stuttgart · New York.)

On August 30, 2010, the German Network for Health Services Research [Deutsches Netzwerk Versorgungsforschung e. V. (DNVF e. V.)] approved the Memorandum III "Methods for Health Services Research", supported by their member societies mentioned as authors and published in this Journal [Gesundheitswesen 2010; 72: 739-748]. Registries in Health Services Research vary in their aims and research questions as well as in their designs, methods of data collection, and statistical analyses. This paper aims to provide both a methodological guideline for developers to ensure a high quality of a planned registry and, to provide an instrument for users of data from registries to assess their overall quality. First, the paper provides a definition of registries and presents an overview of objectives in Health Services Research where registries can be useful. Second, several areas of methodological importance for the development of registries are presented. This includes the different phases of a registry (i. e., conceptual and preliminary design, implementation), technical organisation of a registry, statistical analysis, reporting of results, data protection, and ethical/legal aspects. From these areas, several criteria are deduced to allow the assessment of the quality of a registry. Finally, a checklist to assess a registry's quality is presented., (© Georg Thieme Verlag KG Stuttgart · New York.)