gms | German Medical Science

Background: There is a growing need for database tools to enable structured data collection in clinical studies and biomedical research. The major difficulties arise from constantly changing requirements and the need of flexibility to add any type of new parameters, change selection criteria and perform new analyses without time consuming programming for each individual request. It should also conform to data privacy regulations and should be accessible by many users through the internet.

Methods: Programming was based on a web framework in Ruby on Rails. MySQL was used as database system. The complete software package is running on a Linux or Mac OSX, which acts as a normal server.

Results: The new software enables to generate in a standard browser program tables with user defined names for columns and rows and to enter any type of data including numbers, strings, dates, images or files into each field addressed by the name of the column and the row. Graphical user interfaces guide the user through administrative work (create or delete tables, rows and columns, share data) and data collection (enter new patients, visits, data values). Thus, high flexibility is provided for structuring of CRFs, biobanking information or research data including high-throughput technologies. The database is currently applied for collecting information in the multi-center biomarker research project ArthroMark. For data privacy, different levels of rights to access data are generated for reading, writing and sharing of data as well as administrating the structure of tables. To track entry of data as well as changes performed at a later time point, a log file will be updated constantly. As an example, a data structure for clinical information from patients with arthritis was established.

Conclusion: With the new database any kind of information can be stored including images. Every new parameter can be added without programming knowledge. Many users can access at the same time. Thus the database enables to collect data in the clinics, to share these with scientists, to enable biobanking, or sample tracking. The database is currently part of the BMBF funded national research network ArthroMark and the EU funded network BTCure.