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Keywords

Clinical trials, Clinical nursing research, Controlled vocabulary, Data collection, Information systems

 

Authors

  1. MEADOWS, BEVERLY J. MS, RN, OCN

Abstract

Information regarding the clinical course of a patient in a clinical trial is critical for cancer research. Nurses and clinical research associates must locate data stored in many formats and transfer data to paper case report forms. These forms are associated with a unique protocol document that specifies the set of data to be collected. This paper-based process involves a series of abstractions that pose a significant potential for error. Remote data entry has been advocated to facilitate and streamline the collection of clinical trial data. A systematic process to elicit system requirements from end-users is described as an approach to integrate computer technology with cancer research. Nurses and clinical research associates, as end-users of remote data entry, can provide invaluable input into the requirements necessary to develop an efficient and practical system. By incorporating this input, remote data entry can offer a potential benefit for preserving data integrity.