title: DADOS-Prospective: an open source application for Web-based prospective data collection.
abstract: 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.
authors.affiliation: School of Medicine, University of North Carolina-Chapel Hill, Chapel Hill, NC 27599, USA. ngoc-lam_nguyen@med.unc.edu
authors.forename: Lam
authors.initials: L
authors.lastname: Nguyen
authors.forename: Anand
authors.initials: A
authors.lastname: Shah
authors.forename: Matthew
authors.initials: M
authors.lastname: Harker
authors.forename: Henrique
authors.initials: H
authors.lastname: Martins
authors.forename: Mariana
authors.initials: M
authors.lastname: McCready
authors.forename: Andreia
authors.initials: A
authors.lastname: Menezes
authors.forename: Danny O
authors.initials: DO
authors.lastname: Jacobs
authors.forename: Ricardo
authors.initials: R
authors.lastname: Pietrobon