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Development of the "GeneSYS" database system to support trial data capture and conduct

Background

Data from the recent UK-wide registration process for clinical trials units (CTU) revealed that a significant proportion of units use in-house developed solutions despite the availability of numerous commercial and open source solutions, suggesting these solutions may not meet individual trial requirements. Recognising the need to develop flexible database solutions quickly, and that are easily maintained throughout the life cycle of a study, the CTU database development team conceived and developed the "GeneSYS" database solution.

Methods

GeneSYS allows clinical trial databases to be created without any coding via an intuitive web interface. It simplifies the creation of electronic CRFs, even with complex data validation rules. The web viewer provides an easy to use interface for data collection.

Results

First released in Nov 2012, GeneSYS currently supports eight trials, including two multi-centre trials and two trials run externally to the CTU. It is hosted on a secure NHS server and accessed via the NHS clinical portal. Initial feedback has been very positive. Trial database development time has reduced significantly, thereby increasing our capacity to support more trials. We are investigating developing a mobile viewer so that electronic capture could become the primary data source.

Conclusion

GeneSYS has been a success; it has the potential to support a wider range of trials and to make database creation more efficient and intuitive enough for non-technical staff to author.

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Open Access This article is published under license to BioMed Central Ltd. This is an Open Access article is distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/2.0 ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver ( https://creativecommons.org/publicdomain/zero/1.0/ ) applies to the data made available in this article, unless otherwise stated.

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Hutton, D., Smith, N., Cappel-Porter, H. et al. Development of the "GeneSYS" database system to support trial data capture and conduct. Trials 14, P66 (2013). https://doi.org/10.1186/1745-6215-14-S1-P66

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  • DOI: https://doi.org/10.1186/1745-6215-14-S1-P66

Keywords

  • Clinical Trial Unit
  • Primary Data Source
  • Database Development
  • Validation Rule
  • Clinical Trial Database