Core Unit IT

SP3: IT platform for the Dystonia Translational Research and Therapy Consortium

 Principle Investigator: Gisela Antony

The Core Unit IT implement and maintain the required ITtechnical infrastructure for all network project activities, establish an integrated IT portal, including medical data, images and videos, biomaterial data processing, pseudonymization, content management system and groupware support methods.

In strong cooperation with the project principal investigators it build data set definitions, IT process specifications, work flow definitions, provide nomenclature and ontology specifications and standard operation procedures according to internal and external requirements (GCP, AMG, FDA 21 CFR 11) for the single projects and their scientific interaction in the network as a whole.


sp3 grafik

The objectives are:

  1. Implement and operate an integrated IT infrastructure for the whole research network, including electronic data capture system for medical data, image describing data and images, video describing data and videos, biomaterial administration and tracking, pseudonymization features and interfaces to statistical software based on the existing audited and validated IT equipments of the CIO Marburg.
  2. Provide an integrating IT portal including research network internet website, EDC and pseudonymization systems, project communication and data management support features.
  3. Develop SOPs for quality management and IT-technical processes to guarantee highest methodological standards for data collection including data safety and data protection according to ICH and GCP regulations and TMF guidelines.

Data protection and safety

Data safety is guaranteed by the CIO Marburg, too. Because all legal aspects of data protection are respected by the generic data protection concepts of the TMF e.V. the concept for the DysTract consortium was created according to these guidelines. The generic data protection concepts of the TMF e. V. provides details on organization and legal form, ethical and legal issues in the creation of a clinical data base, a systematic method for collecting data, protocols for request, analysis, export of and access to data, guidelines for pseudonymisation; data trustee concepts and regulations for participating in the collected data for non-member researchers.

If the status of a patient is turned to “deceased” in the “patient status” form, the system sends an internal message to all center members and authorized investigators, lock the pseudonym’s data immediately, and send a demand to the data manager to delete the pseudonym and all corresponding data.

All persons authorized for data input are part of the secuTrial® sophisticated user, privilege and roll system. Patients as well as authorized persons are relocated to the enclosed centers (hospitals, medical practices, study groups in connection to treatment) due to data protection law and protection of data privacy. The allocation of rights to single rolls or single centers is defined due to different research groups intentions and needs.

The system is able to administrate as many centers with as many investigators as wanted; all investigators to only one center or several investigators to different centers. Moreover it can give authorized user access to single, some or all forms, single, some or all reports and statistics. The eCRF form families of the EDC system react interactive with these rights and rolls.

Data quality assurance

The secuTrial® system allows the implementation of unlimited plausibility and completeness checks, which protects the medical data base and prompt the center staff during data entry immediately for appropriate action. Furthermore each data change is noted together with user name, date and time in the audit trail, according to requirements of GCP and FDA (21 CFR Part 11). The audit trail includes all data inputs and changes and all database queries. Therefore it is always possible to reconstruct who was responsible for creating, changing or deleting any single data or database query.