PC58 ELECTRONIC DATA CAPTURE AND USE OF INTERNET TECHNOLOGIES IN A DOUBLE-BLIND RANDOMISED INTERVENTION TRIAL

Abstract

Introduction: The CHOPIN-study (Childhood Obesity Programming by Infant Nutrition)is a multicentre double-blind randomised clinical trial which is performed in 5 European countries. In order to test the hypothesis that a high protein intake in early life is related to early markers of childhood obesity a total of 1000 formula fed and 250 breast fed infants in 5 European countries are being closely followed up for 2 years. Managing a multicentre clinical trial amongst other things requires efficient data collection, review and integration. Methods: In comparison with traditional Data Capture (DC) where data are transcribed from paper records into a database Electronic Data Capture (EDC) enables to directly record data on-site, using preconfigured software instead of the traditional paper form. EDC therefore eliminates the need for data transcription. Edit checks and validation can be applied immediately, eliminating errors that routinely create queries several months later in paper-based processes. In the CHOPIN study EDC is used for remote data entry (RDE) which means that information that is entered on-site is transferred via the internet to a central database thus unifying the data of five clinical study centres. In the CHOPIN study EDC for RDE was implemented in two ways –by providing a preconfigured laptop to an investigating doctor (offline system), and by using the internet for online data entry to a central system (online system). Results: EDC for RDE was successfully implemented into the data gathering and processing procedure of the multicentre double-blind randomised clinical trial CHOPIN. As data are cleaned during the electronic case report form (CRF) completion by the clinical staff, time to data base lock is reduced compared to the paper based process. Although the CHOPIN study is still ongoing, it can be foreseen, that fieldworkers will benefit from this main advantage of EDC, rapid data availability, provided that the majority of fieldworkers does without interim paper CRFs. Considerable planning, however, is necessary upfront whereas a quick start can be managed in the paper based process. Conclusion: Considering the pros and cons of electronic data capture for remote data entry, in the Chopin study the advantages clearly outweigh the disadvantages. This methodology can therefore be recommended for the use in multicentre clinical trials.