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The article presents a study that aims to develop a concept for legally secure and technically feasible archiving of a whole clinical trial. Study shows that the trial master file has a complex structure, having different parts that can vary greatly in size, depending of the working style of investigators, patients, and adverse event reports. Hence, the authors conclude that there is a need for new solutions by the complexity and size of the trial master file.

[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.

COVID-19 has challenged the healthcare systems worldwide. To quickly identify successful diagnostic and therapeutic approaches large data sharing approaches are inevitable. Though organizational clinical data are abundant, many of them are available only in isolated silos and largely inaccessible to external researchers. To overcome and tackle this challenge the university medicine network (comprising all 36 German university hospitals) has been founded in April 2020 to coordinate COVID-19 action plans, diagnostic and therapeutic strategies and collaborative research activities. 13 projects were initiated from which the CODEX project, aiming at the development of a Germany-wide Covid-19 Data Exchange Platform, is presented in this publication. We illustrate the conceptual design, the stepwise development and deployment, first results and the current status.

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.)

Objective: Within translational research projects in the recent years large biobanks have been established, mostly supported by homegrown, proprietary software solutions. No general requirements for biobanking IT infrastructures have been published yet. This paper presents an exemplary biobanking IT architecture, a requirements specification for a biorepository management tool and exemplary illustrations of three major types of requirements., Methods: We have pursued a comprehensive literature review for biobanking IT solutions and established an interdisciplinary expert panel for creating the requirements specification. The exemplary illustrations were derived from a requirements analysis within two university hospitals., Results: The requirements specification comprises a catalog with more than 130 detailed requirements grouped into 3 major categories and 20 subcategories. Special attention is given to multitenancy capabilities in order to support the project-specific definition of varying research and bio-banking contexts, the definition of workflows to track sample processing, sample transportation and sample storage and the automated integration of preanalytic handling and storage robots., Conclusion: IT support for biobanking projects can be based on a federated architectural framework comprising primary data sources for clinical annotations, a pseudonymization service, a clinical data warehouse with a flexible and user-friendly query interface and a biorepository management system. Flexibility and scalability of all such components are vital since large medical facilities such as university hospitals will have to support biobanking for varying monocentric and multicentric research scenarios and multiple medical clients.

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.)