DADOS-Prospective: an open source application for Web-based prospective data collection.
BACKGROUND
Randomized, prospective trials involving multi-institutional collaboration have become a central part of clinical and translational research. However, data management and coordination of multi-center studies is a complex process that involves developing systems for data collection and quality control, tracking data queries and resolutions, as well as developing communication procedures. We describe DADOS-Prospective, an open-source Web-based application for collecting and managing prospective data on human subjects for clinical and translational trials. DADOS-Prospective not only permits users to create new clinical research forms (CRF) and supports electronic signatures, but also offers the advantage of containing, in a single environment, raw research data in downloadable spreadsheet format, source documentation and regulatory files stored in PDF format, and audit trails.


RESULTS
Feedback from formal and field usability tests was used to guide the design and development of DADOS-Prospective. To date, DADOS-Prospective has been implemented in five prospective clinical studies at our institution. Four of these studies are still in the CRF creation phase and one study has been entirely launched.


CONCLUSIONS
DADOS-Prospective has significant advantages over existing Web-based data collecting programs. At our institution, it has been demonstrated to be an efficient tool for prospective clinical studies.
Nguyen
Lam
L
School of Medicine, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA. ngoc-lam_nguyen@med.unc.edu
Shah
Anand
A
Harker
Matthew
M
Martins
Henrique
H
McCready
Mariana
M
Menezes
Andreia
A
Jacobs
Danny O
DO
Pietrobon
Ricardo
R