Supporting IITs

i2b2 has turned out to be a very valuable component for secondary use of routine clinical data. Its pragmatic database schema allows merging of data from heterogeneous data sources, and the intuitive user interface enables easy querying and powerful processing. However, it's a component rather than a complete solution: The user is facing several barriers when integrating i2b2 into the operational workflow. Even though the i2b2 team did an exceptionally good job in documenting the whole system and providing an easy-to-use virtual machine for demonstration purposes, it's still hard to combine i2b2 with custom solutions. Although the database schema is easy to understand, a significant effort has to be spent to preprocess and import data as i2b2 provides only limited support for importing data through the workbench, but no way to automate a suitable ETL process (Extraction, Transformation and Loading). This also applies for terminologies that are required to access the data. The Integrated Data Repository Toolkit (IDRT) was conceived to address both the issue of setup and administration as well as the ability to import clinical data in several standard formats, including terminologies.

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Primary database for standardised storage of microbiology data

This software makes it possible to store microbiology data based on standardised criteria, simplifying the transfer of data within an institute and between research partners working in the same area. The data categories were defined by researchers and programmers from various disciplines of microbiology research. The software package is accompanied by a comprehensive user guide.

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Repository for standardised study data elements

Defining how data will be captured and documented in clinical and epidemiological studies and registries takes up a significant amount of time and effort in the preparatory stage of any project. The validity and quality of a study can be influenced significantly by the precision of metadata specification – and the use of flawed or carelessly defined data elements is very difficult to correct retrospectively. Moreover, standard data elements should be deployed in order to enable future integration of data within the scope of meta-analyses.  The National Metadata Repository (MDR) assists researchers with these efforts, by providing harmonised data elements and categories.

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Online Registry of Biobanks in Germany

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TMF hosting service for the use of SAE management software VigilanceONE via remote access (ASP)

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Legal opinion on electronic storage of documents and data files in the context of clinical trials

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TMF macro collection for the SAS software for the evaluation of clinical studies

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Software assistant for web-based use of the TMF checklist for creation of patient information and informed consent

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Software for the use of a specialized TMF IT infrastructure for the symmetrical encryption of single-level pseudonyms

Software for two-stage pseudonymization of medical data for the development of research databases that can be used in the long term. Available since the end of 2009 following reconceptualization and reimplementation. In conjunction with tools for the administration of single-level pseudonyms it enables data protection-compliant development of new kinds of research databases with long-term merging of follow-up data sets and person-related feedback of research results.

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Access to a web portal with specialized tools for joint creation and consenting of medical guidelines including user support and services

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