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Clinical trials are the engine for pharmaceutical innovation, but their means of capturing and communicatingdata are stuck in the past. In most cases, the EHRs and EDCs don’t communicate, so in order to share that data with trial organisers, staff members at medical centres must manually copy data between the EHR and an EDC.
ISPE GAMP® Guide: Records and Data Integrity. North Bethesda, MD: International Society for Pharmaceutical Engineering, 2017. Based on robust data flows, aspects and required controls can be assessed in detail—for example, manual dataentry, interfaces between systems, media change, data conversion, data migration, and data archiving.
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