Abstract
In the Organon International approach to remote data entry, centralized and decentralized activities are combined on the basis of functional criteria: security, minimization of effort, consistency, speed of operation, and auditability of the system. Centrally managed facilities for performing off-line remote data entry are located at the local clinical research associate's office, and connected via the public data network (X-25) to a central database where storage, validation, coding, and reporting are performed.
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