Abstract
BackgroundTraditionally, clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records. Although well established, this method is time-consuming and error-prone. This study compares four electronic data capture (EDC) methods with the conventional approach with respect to duration of data capture and accuracy. It was performed in a West African setting, where clinical trials involve data collection from urban, rural and often remote locations.Methodology/Principal FindingsThree types of commonly available EDC tools were assessed in face-to-face interviews; netbook, PDA, and tablet PC. EDC performance during telephone interviews via mobile phone was evaluated as a fourth method. The Graeco Latin square study design allowed comparison of all four methods to standard paper-based recording followed by data double entry while controlling simultaneously for possible confounding factors such as interview order, interviewer and interviewee. Over a study period of three weeks the error rates decreased considerably for all EDC methods. In the last week of the study the data accuracy for the netbook (5.1%, CI95%: 3.5–7.2%) and the tablet PC (5.2%, CI95%: 3.7–7.4%) was not significantly different from the accuracy of the conventional paper-based method (3.6%, CI95%: 2.2–5.5%), but error rates for the PDA (7.9%, CI95%: 6.0–10.5%) and telephone (6.3%, CI95% 4.6–8.6%) remained significantly higher. While EDC-interviews take slightly longer, data become readily available after download, making EDC more time effective. Free text and date fields were associated with higher error rates than numerical, single select and skip fields.ConclusionsEDC solutions have the potential to produce similar data accuracy compared to paper-based methods. Given the considerable reduction in the time from data collection to database lock, EDC holds the promise to reduce research-associated costs. However, the successful implementation of EDC requires adjustment of work processes and reallocation of resources.
Highlights
Conventional data collection for clinical and scientific trials has focused on paper-based case report forms (CRF) followed by double data entry into a relational database
electronic data capture (EDC) solutions have the potential to produce similar data accuracy compared to paper-based methods
Due to problems with the partial date function in OpenClinicaH, which led to inconsistent swaps of the day and month fields within a date during the data extraction process, only 111 fields per CRF were analyzed; 25 (22.5%) text, 10 (9.0%) date, 6 (5.4%) numerical, 37 (33.3%) single select and 33 (29.7%) skip questions. 3 (9.1%) of the skip questions were text fields, 9 (27.3%) numerical, and 21 (63.6%) single select fields
Summary
Conventional data collection for clinical and scientific trials has focused on paper-based case report forms (CRF) followed by double data entry into a relational database. Title 21 CFR Part 11 of the Code of Federal Regulations [5] deals with the FDA guidelines on electronic records and electronic signature in the United States It defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Clinical research studies rely on collecting data with case report forms, which are subsequently entered into a database to create electronic records Well established, this method is time-consuming and errorprone. This study compares four electronic data capture (EDC) methods with the conventional approach with respect to duration of data capture and accuracy It was performed in a West African setting, where clinical trials involve data collection from urban, rural and often remote locations
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