Simplifying electronic data capture in clinical trials: workflow embedded image and biosignal file integration and analysis via web services.

ABSTRACT: To improve data quality and save cost, clinical trials are nowadays performed using electronic data capture systems (EDCS) providing electronic case report forms (eCRF) instead of paper-based CRFs. However, such EDCS are insufficiently integrated into the medical workflow and lack in interfacing with other study-related systems. In addition, most EDCS are unable to handle image and biosignal data, although electrocardiography (EGC, as example for one-dimensional (1D) data), ultrasound (2D data), or magnetic resonance imaging (3D data) have been established as surrogate endpoints in clinical trials. In this paper, an integrated workflow based on OpenClinica, one of the world's largest EDCS, is presented. Our approach consists of three components for (i) sharing of study metadata, (ii) integ

SUBMITTER: Haak D 

PROVIDER: S-EPMC4171435 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature