report: Piloting Paperless Data Entry for Clinical Research in Africa

Abstract. Direct data entry, using handheld computers, may simplify and streamline data management, especially in remote settings. We compared the accuracy of data entry using the current standard practice (a paper-based case report form with double data entry) with that using a personal digital assistant (PDA) in a clinical study in rural Gabon. The rate of discrepant entries was 1.7%. Categorical data (presented in “pull down ” menus on the PDA) were more commonly discrepant than were continuous “typed in ” data (2.4 % versus 1.2%; P 0.001). Both systems functioned smoothly and no data were lost. The clinicians involved in this study preferred the handheld computers, and their use will be considered in future studies in an African clinical research network. Quick, accurate data entry is required for clinical research studies. Patient data are commonly recorded on paper-based case report forms (CRFs). These are useful for data verifica-tion, allow tracking of corrections, and provide documenta-tion. The current standard is to use a “double data entry” system. The data are entered from the CRF by two different individuals, the two databases are compared, and any discrep-ancies are addressed by double checking either the CRF o