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(Letzte Aktualisierung: 12.02.14)

IT infrastructure

IT infrastructure for clinical research

One of the TMF’s tasks is to coordinate and efficiently organize the development and operation of clinical research infrastructure.

Promotion of clinical research in Germany aims, in particular, to create long-term organizational infrastructures that enable multi-center clinical trials to be carried out more quickly, more economically and at a higher standard, also facilitating the development and operation of clinical registers and biobanking. As an umbrella organization for networked medical research, the TMF is responsible for the coordination and efficient organization of the development and maintenance of infrastructures that are essential for clinical research.

The processes that require support are extremely complex, heterogeneous and subject to change. This turns the conception, identification and development of suitable IT solutions into a major challenge. The goals can therefore only be achieved by pursuing different strategies simultaneously: wherever possible, processes should be analyzed, harmonized and modeled in order to enable them to be ideally reproduced using software. Where such harmonization is not possible, the modular conception of IT solutions and the use of standardized interfaces must be alternatively pursued in order to guarantee system integration. That is why the TMF projects often comprise a pragmatic mix of both strategies.

Contact person at the TMF Office

Johannes Drepper

Phone: +49 30 31 01 19 53


Products related to this topic

(You will find further products in the overview of TMF products.)

P101401 - ToolPool Health Research

P101201 - Survey and recommendations for the German-speaking countries

P101001 - Tools to integrate data in i2b2

P100901 - Descriptions of IT requirements for cohorts and registers

P100801 - Primary database for microbiology data

P100701 - Phase II package

P100401 - Architecture for patient recruitment from hospital information systems (HIS)

P100301 - R-Program package for optimisation and flexible adaptation of multi-stage designs for genome-wide association studies

P100201 - Software prevent the re-identification

P100101 - National Metadata Repository

P042041 - Expert Opinion on economic aspects of electronic archiving

P042031 - Expert Opinion on the use of CDISC-ODM for electronic archiving

P042021 - Expert Opinion on conventional file formats for electronic archiving

P999112 - Narrative script for pharmacovigilance software

P999111 - Report templates for pharmakovigilance software

P014012 - Software library for data protection concept (model A)

P999071 - Specimen contracts - Contracted software developement and cession of utilisation rights

P999031 - Licence granting for SAE software

P999021 - Hosting for SAE software

P052012 - Specimen Contract for data custodianship

P052011 - Legal Opinion on data custodianship

P042011 - Legal Opinion on electronic archiving

P034011 - SDTM converter

P021011 - SAS macros for clinical studies

P019013 - System validation – Training documentation

P019012 - Audit concepts for computer systems

P019011 - System validation master plan

P015011 - PID generator

P000011 - Pseudonymisation software

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