Availability of Electronic Data Capture versus Paper-Based Data Collection in a Post-Marketing Study for Medicine

Abstract

 The authors examined a post-marketing study of a medicine that was performed by combining both an electronic collection based on an electronic data capture (EDC) system and a paper-based collection. The electronic collection and the paper-based collection were compared in terms of: ①the time from the date of commencing a contract with a participating site for the post-marketing study until the date of obtaining a case report form; ②the time from the date of obtaining a case report form until the request for re-questionnaire of the case report form; ③the time required for re-questionnaire of the case report form; ④the time required for check on the case report form; ⑤the time from the date of commencing a contract with a participating site for the post-marketing study until finalizing the case report form; ⑥the re-questionnaire rate; and ⑦the mean number of items re-questioned per case report form. ①, ②, ③ and ④ was shortened for the electronic collection compared with the paper-based collection. ⑥ was 37.8% for the electronic collection compared with 75.8% for the paper-based collection. ⑦ was 1.5 items out of a total of 92 items with the electronic collection whereas it was 8.5 items with the paper-based collection. These results concerning the availability of EDC system for post-marketing studies suggested that the system can improve the efficiency of clinical patient data verification.