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Nightscout is a collection of software tools, including mobile clients, to enable DIY cloud-based continuous glucose monitoring "…for informational and educational purposes." [ 31 ] Individual components are available under various open-source licenses, including the GNU GPL , [ 32 ] GNU AGPL , [ 33 ] MIT License , [ 34 ] and BSD licenses .
The development of the ISO 9000-3 standard [9] as well as the European Medical Devices Directive in 1993 [1] helped bring some harmonization of existing laws with medical devices and their associated software, and the addition of IEC 62304 in 2006 further cemented how medical device software should be developed and tested. [11]
A Clinical Trial Management System (CTMS) is a software system used by biotechnology and pharmaceutical industries to manage clinical trials in clinical research.The system maintains and manages planning, performing and reporting functions, along with participant contact information, tracking deadlines and milestones.
Reusing software modules does not guarantee safety in the new system to which they are transferred ..." [6] In response to incidents like those associated with Therac-25, the IEC 62304 standard was created, which introduces development life cycle standards for medical device software and specific guidance on using software of unknown pedigree. [10]
A clinical data management system or CDMS is a tool used in clinical research to manage the data of a clinical trial. The clinical trial data gathered at the investigator site in the case report form are stored in the CDMS. To reduce the possibility of errors due to human entry, the systems employ various means to verify the data.
CDE initiatives, for example, try to allow clinical trial designers to adopt standardized research instruments (electronic case report forms). [14] A parallel effort to standardizing how data is collected are initiatives that offer de-identified patient level clinical study data to be downloaded by researchers who wish to re-use this data.
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