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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]

Modern decision support and assistance systems use distributed data sources from private and public providers through specialised web services in order to enhance the provision of information. POHL et al. (2021) present a web service-dominated procedure for the generation of site-specific pesticide application maps by bringing together all required data via web services and other interfaces in the application map service. This paper presents the central services that make it possible to provide site-specific ecological and economic key data and basic information in crop protection. We show how this web service contributes to an automated determination of distance requirements in real time, and discuss the limits of this approach and system. In accordance with the Amendment of the E-Government Act (EGovG) and the introduction of the Act for the Use of Public Sector Data (DNG), the technical documentation of all the REST-compliant programming interfaces have been implemented in accordance with the OpenAPI standard. [ABSTRACT FROM AUTHOR]