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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]

Digital learning and self-assessment tools have gained importance in medical education over the last years and are pushing back print media more and more. They enable flexible learning that is aligned with current state exams and the latest scientific findings. Embedded videos, interactive graphics and practice questions offer a more diverse learning experience than using books alone. While the commercial learning tools cover the state examinations' content well, they often lack what is additionally taught in different faculties. At the same time, the dominance of a few providers is tied to rising costs for students or to provide campus licenses. Faculties may thus offer literature and learning platforms of less variety, and an intensive and broad examination of subjects and problems is made more difficult. The promotion and nationwide availability of locally initiated non-commercial learning and examination tools can counteract this development. Electronic learning platforms enable efficient exam preparation with the presentation of exam questions. Paper-based preparatory exams have already been almost completely replaced by their electronic counterparts. Digital exams offer decisive advantages over paper-based exams, for example with the embedding of video sequences and increased feasibility of sequential questions, and should become standard not only in exam preparation. [ABSTRACT FROM AUTHOR]