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Development of a Clinical Database System for Glaucoma Patients using Remote Data Entry

1Troost R., 2Vogel A., 3Wagner M., 2Schwenn O.,
1Johannes-Gutenberg-Universität Mainz, Koordinierungszentrum für Klinische Studien (KKS) (Mainz)
2Johannes-Gutenberg-Universität Mainz, Universitäts-Augenklinik (Mainz)
3IMBEI (Mainz)

Purpose: Quality of clinical data is a crucial factor for valid results and conclusions in clinical research. Inappropriate data management tools and isolated data sets on project level may lead to bad data quality and complicates comprehensive analyses. Our aim was the development of a modular, extendable data management concept utilizing modern communication technology. Based on that a clinical database system for glaucoma diseases should be developed.
Method: At the Coordination Centre for Clinical Trials Mainz a remote data entry system was set up to support data management activities in clinical research. International standards (FDA- and ICH-GCP guidelines) have been considered. A centralized system architecture ensures data integrity and confidentiality. Access is restricted to authorized users only. All data management activities are performed according to standard operating procedures.
Results: A database application was deployed which can be accessed via the university hospital´s intranet. Any changes on data are stored automatically in a central audit trail. Build in edit checks help to avoid entry of incorrect data and therefore improved the quality and credibility of data. Seperate study projects can be integrated and facilitate overall analyses.
Conclusions: Our data management concept offers a consistent, secure and comprehensible electronic data capture tool in glaucoma research. Moreover the modular structure supports integration of future study projects and trials.