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Remote data entry

A remote data entry (RDE) system is a computerized system designed for the collection of clinical trial data in electronic format. The term is most commonly applied to early software in the life sciences industry that allowed investigators to collect patient data from participants in clinical research studies, such as trials of new drugs or medical devices.

Typically, RDE systems provide:

  • a graphical user interface for data entry,
  • a validation component to check user data, and
  • a reporting tool for analyzing the collected information.

The development of RDE systems began in the mid- to late-1980s, often installed on portable computers equipped with modems. Since the early 2000s, RDE has been largely replaced by electronic data capture (EDC), which provides the same functionality via internet-based platforms and web pages.

References

References

  1. Prokscha, Stephan. (2011). "Practical Guide to Clinical Data Management". Springer.
  2. U.S. Food and Drug Administration (FDA). (2007). "Guidance for Industry: Computerized Systems Used in Clinical Investigations". FDA.
  3. Nahm, Meredith. (2004). "Data standards in clinical research: fundamental concepts". MAGI.
  4. Kush, Rebecca. (2003). "EDC and Clinical Data Management". Thomson CenterWatch.
  5. Pavlovic, Ivana. (2009). "Electronic data capture in clinical trials: an opportunity for transforming clinical research". Applied Clinical Trials.
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clinical-research pharmaceutical-industry clinical-data-management
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