1. A clinical database for networking in multicenter studies Ulrike Haase 1, Marc Bonin 1, Stephan Flemming 2, Frank Buttgereit 1, Till Sörensen 1, Thomas Häupl 1 1 Department of Rheumatology and Clinical Immunology, Charité University Hospital, Berlin 2 Pharmaceutical Bioinformatics, Institute of Pharmaceutical Sciences, University of Freiburg Motivation Aim of this project was to develop a clinical database system for sharing of clinical information in multicenter research studies. The system should be flexible to store any kind of data and to enable the user to include any new parameter. It should also conform to data privacy regulations and should be accessible through the internet. Methods Programming was based on a web framework in Ruby on Rails. MySQL was used as database system (Figure 1). The complete software package is running on a virtual machine with Windows 7, which acts as a normal server. Results For storage of clinical information, two tables were defined. The first table contains all data in structured format, the second table harbors all information about the structure for each type of parameter. In detail, one or more values of a given parameter are linked to two different masterkeys and three different parameter keys (Figure 2). The masterkeys define the patient identity (patient-ID) and the time point of the visit (Figure 3). The parameter keys define the structure of tables (names of the tables, the rows, and the columns), which can be generated by the user to store clinical information (Figure 3). As an example, a data structure for clinical information from patients with rheumatoid arthritis was established (Figure 3 + 4). In addition, a system of user and data specific rights was established to own and share data for reading, writing and administrating rights (Figure 5). 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). Conclusion With the new database any kind of information can be stored including images. Every new parameter e.g. new tables, rows or columns can be added without programming knowledge. Many users can access at the same time from their own PC via an internet browser. Access is protected via user specific login and different levels of rights. 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 national research network Arthromark (BMBF-funded), the EU-network NanoDiaRA (EU-funded) and the German- Singaporean collaboration DeSiNet- Rheuma (BMBF-IB-funded) (Figure 6). Thomas Häupl, MD Department of Rheumatology and Clinical Immunology Bioinformatics Group Charité University Hospital Charitéplatz 1 D-10117 Berlin Germany phone: +49 30 450 513 291 fax:+49 30 450 7 513 291 e-mail:thomas.haeupl@charite.de Contact: Ulrike Haase Department of Rheumatology and Clinical Immunology Bioinformatics Group Charité University Hospital Charitéplatz 1 D-10117 Berlin Germany phone: +49 30 450 513 296 fax:+49 30 450 513 968 e-mail:u.haase@charite.de Figure 6 Collaborating Networks Table name diagnostics Parameterkey 2 Parameterkey 3 Parameterkey 1 Beginn of symptoms Date of diagnostics End of disease rheumatoid arthritis 02/200806/2008 diabetes mellitus 06/200912/2009 arterial hypertonia 12/2010 pneumonia 03/2011 04/2011 value (date) Row names e.g. rheumatoid arthritis Column names e.g. Begin of symptoms Diagnostics Figure 2 1.Table in database : saving the structered data sets 2. Table in database : structure information Figure 1 Database system Web framework Ruby on Rails Clinical Database - Aims sharing of clinical information in multicenter research studies flexible system should store any kind of data should enable the user to include any new parameter conform to data privacy regulations should be accessible through the internet Aims of the clinical database and used methods (software) medBio ClinicDB Parameter-key 1Parameter-key 2Parameter-key 3data typevalues… laboratoryCrPValueNumber laboratoryCrPUnitStringmg/l, mg/dl laboratoryCrPReference rangeString ……… IDMaster- key 1 Master- key 2 Master- key 3 Parameter- key 1 Parameter -key 2 Parameter- key 3 Value Number Value String Value Date UserCreated at ……………………………… Consecutively items Logs „who“ saved the data „when“ define data type for input data input options for user Figure 3 Masterkey 1 for storing patient specific data (common data about patient) for storing patient and visit specific data (visit dependent data about patient) Parameterkey 2 Parameterkey 3 Parameterkey 1 ValueUnitStandard Value CrP 0.7mg/dl0.5 ESR 1h 30mm/1h 15 ESR 2h 50mm/2h 30 white blood cells (WBC) 7.3/nl4..10 value (number,string) Laboratory + Patients (Patient-ID) Masterkey 2 Visits (visit date) Masterkey 1 Patients (Patient-ID) Figure 4 A table example taken from the clinical database for rheumatoid arthritis. The rectangles with dotted lines show the types of defining parameters (masterkeys, paramaterkeys and values) Masterkey 1 Masterkey 2 Parameterkey 1 Figure 5 sharing all data from one patient (patient-ID 165) Value different levels of user rights Choose which data should be shared The main two tables in the database for saving the data sets and its structure Definition of masterkeys and parameterkeys Parameterkey 3 values (number,string)Parameterkey 2