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) integration of large volume data into eCRFs, and (iii) automatic image and biosignal analysis. In all components, metadata is transferred between systems using web services and JavaScript, and binary large objects (BLOBs) are sent via the secure file transfer protocol and hypertext transfer protocol. We applied the close-looped workflow in a multicenter study, where long term (7 days/24 h) Holter ECG monitoring is acquired on subjects with diabetes. Study metadata is automatically transferred into OpenClinica, the 4 GB BLOBs are seamlessly integrated into the eCRF, automatically processed, and the results of signal analysis are written back into the eCRF immediately.

Fig. 1

Conventional EDC workflow in clinical trials with biosignal data acquisition and analysis

Fig. 2

Workflow of the analysis module with metadata and file transfer side

Fig. 3

Interfacing and architecture of SMT and OpenClinica

Fig. 4

Integrated data entry workflow

Fig. 5

Results. Metadata is shared between SMT and EDCS using the interface module (top); ECG recordings are integrated in OpenClinica using the data module OC Big (middle); and results of quality checks are entered into the eCRF using the analysis module (bottom)

Fig. 6

Workflow of EDC in the EFSD study with support by an EDCS interfacing data and analysis functionality