Volume 5 Supplement 1
© Cavelaars et al; licensee BioMed Central Ltd. 2015
Published: 22 May 2015
Software tool, CDMS (clinical data management system), clinical trials, eCRF, open source community edition.
OpenClinica is an electronic Case Report Form (eCRF) tool designed to capture clinical trial data. The tool is web-based and thus can be accessed from most locations in the world to support multi-center studies. It is a ‘do-it-yourself’ tool: users can operate all the modules and functions that are described below and system administrators are not required to perform study specific actions .
OpenClinica is an open source tool and has two editions: Community and Enterprise edition. The OpenClinica Community edition is freely available, while the Enterprise edition has additional capabilities, is commercially supported and is therefore subject to a license fee. The CTMM-TraIT (Translational Research IT) project aims to establish a long-lasting IT infrastructure for translational biomedical research in the Netherlands and hosts the OpenClinica Community edition. The CTMM-TraIT OpenClinica server is currently used for data capture in 120 clinical studies involving 600 users from 146 different centers.
Status of development
OpenClinica Community Version: 3.4 (October 2014).
A large international user community exists (clinical researchers, data managers)
Supported by CTMM-TraIT project (sustainable IT Infrastructure for Translational Biomedical Research).
- Smeets E, Visser GR: OpenClinica’s (low cost) eCRF, an Investigator-Initiated Study’s Showcase. Applied Clinical Trials-Online. 2011, Available online: http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=726346Google Scholar
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