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Information Technology
Summary of IT responsibilities:
- Preparation and provision of informational bases for conducting clinical trials
- Quality assured development, validation and maintenance of custom applications for management, administration and registration of projects, as well as coding of AEs/SAEs
- Installation, support, maintenance and validation in conformance with GCP of commercial off-the-shelf software, such as those necessary for SUSAR administration or for remote data entry
- Representation of the Clinical Trials Unit in the working groups IT infrastructure and quality management as well as data protection of the TMF registered association, a nationwide network of medical research networks
The IT division provides the technical infrastructure by means which clinical trials can be prepared, conducted and assessed. Compliance with relevant legal guidelines and formalities (AMG, GCP, Data Protection) is always provided.
The IT employees are responsible for the installation and maintenance of over 50 workstations with various operating systems at two locations and maintain the internal web, file and applications servers. They make the centrally provided services of the University Medical Center available in house and adapt them to their own system.
Central services such as email, the University Medical Center's patient databases and the University Medical Center's firewall software are maintained, as well as software which is only used by the Clinical Trials Unit. This includes for example, an RDE (remote data entry) Tool, which is operated in various versions at the same time, and a program for the administration and notification of SUSARs, or the statistics program SAS. These programs demand a high level of availability in GCP relevant processes and must therefore be kept up-to-date.
Besides supervising purchased software the IT division also develops its own software. If a commercial system is not available this is the only remaining possibility. Therefore, the study registers were developed by ourselves and have been in operation for years. The Clinical Trials Unit plays a leading role in the development and servicing of study registers, both at the local and national level. It is represented in various working groups, for example, the WHO by scientific-medical and scientific-technical employees. In their development current technologies are adopted and used. Therefore we use, for example, data exchange in XML, as well as version controlling with Subversion in all stages of development or unit tests of our own specially developed program modules. Custom applications for management, administration and registration of projects, as well as the coding of AEs/SAEs are developed in a quality assured way, validated and maintained.
In addition, the IT division of the Clinical Trials Unit represents the IT infrastructure and quality management, as well as data protection of the TMF registered association, a nationwide association of medical research networks. The TMF offers the opportunity to exchange with colleagues and to conduct common projects in order to support clinical research of patients in a quality assured and informative way.
