Survey Results of Remote Data Entry Use by Clinical Investigator Sites

Abstract

A survey was conducted to determine the effects of remote data entry (RDE) on investigators, their staff and facilities during the performance of a clinical trial. Two hundred two of the 415 surveyed responded. Ninety-five (47%) had used RDE in at least one previous clinical trial. RDE had a definite impact on the study facility and personnel. The cohort did not have extensive previous computer experience; however, this was not a problem in that sponsor training was reported excellent or adequate by almost all respondents. The majority believed that the hardware and software were either excellent or adequate. Anticipated advantages for RDE to reduce errors, missing data, file storage and improve auditing were not reported by a majority of the cohort. Overall, the benefits of RDE were perceived to accrue most often to the sponsor and not the study site per se. Nevertheless, the general opinion of RDE was favorable