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The single-source proof-of-concept study is a study published in 2007 and sponsored by the Clinical Data Standards Interchange Consortium (CDSIC) in an initiative designed to simplify and improve the process of the capture of data during point-of-care testing. The study demonstrated the reuse of patient data for clinical trials within electronic medical records in clinical research.
It is also known as the STARBRITE proof-of-concept study.
Single-source proof of concept is a method of data capture that eradicates double-data entry, cuts down on workflow disruption and boosts the reuse of electronic patient data within active clinical trials. Existing data standards were used from the Clinical Data Interchange Standards Consortium and HL7 for database supplementation and clinical document exchange. System development took place after careful analysis of case report forms, clinic notes, clinic workflows and business patterns and procedures.
The data that was used in this study was recorded in real time during patient visits and it also generated electronic medical records from clinic visits. System development analyses provided pertinent information regarding systems implementation practicalities that routinely extract, store and reuse healthcare data. These practices will very likely be applied to many clinical trials.
The single-source proof-of-concept work within the STARBRITE study was sponsored by the Duke Clinical Research Institute, the Microsoft Corp. and the CDISC. Novartis, Merck & Co. Inc., Digital Infuzion and Topsail Technologies Inc. were also sponsors.