Abstract

In 2001, a survey was conducted by the eClinical Forum to explore the experience, needs, views and issues of investigational site staff with respect to Electronic Data Capture (EDC). 836 investigational staff responded in 2001 primarily from Europe and North America with only 21 responders from Asia.  The survey was repeated in 2009, with the aim of identifying how experiences and expectations have changed between 2001 and 2009, toexplore the trends for the future of efficient data capture for clinical trialsand to research opinions on the use of emerging eClinical technologies.  784 complete responses were received fromsite staff but with significant growth in numbers from Asia (at 466 responders,the majority of whom were based in Japan).

The key areas of change over the 8 yearsare significant growth in the use of EDC (from 14% in 201 to 58% of allon-going trials in 2009) and the changed role of the Study Coordinator in theentry and review of EDC data. In 2009, respondents were concerned aboutduplication of data between the Electronic Health Record (EHR) and the ClinicalTrial system and 72% saw benefit in electronic exchange of data between healthcareand research systems.  A growing concernwas expressed by responders about the appropriateness of entering data into anEDC system in front of the patient (in 2001 19% felt it was never appropriate comparedwith 36% in 2009). The reluctance was particularly strong in Asia at 74%.