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(Letzte Aktualisierung: 12.02.14)

Supporting IITs

Prerequisites and infrastructure for carrying out science-initiated trials

One of the TMF’s core tasks is the improvement of the prerequisites and infrastructure for carrying out science-initiated, non-commercial clinical trials. Expert opinions, checklists and training documentation are available to this end which have been developed in joint projects aimed at analyzing and preparing the legal framework. At the same time, projects for the selection and development of software tools for use in clinical tests were carried out, for example software systems for "Remote Data Entry" (RDE) and the electronic reporting of serious adverse events (SAE) in clinical trials including central hosting.

In addition, the TMF commissioned, amongst other things, the development of tools for the standardized preparation and evaluation of data from clinical trials and made this information available to research centers. In its endeavors, the TMF placed great emphasis on the use and support of international standards. As regards the CDISC standards in particular a series of TMF projects in Germany’s research landscape has resulted in the development of unique expertise which, in the future, can be used to a greater extent to further develop these standards.

In addition to the use of existing and, in part, established standards such as CDISC and HL7 together with the relevant memberships, the problem of poor semantic harmonization is being increasingly identified and picked up by TMF projects. The establishment of cross-study research databases that can be used in the long term and whose compliance with data protection regulations can be ensured with aid of the TMF data protection concepts and tools, makes great demands in terms of standardized, informative terminology that can be used for a wide range of technical fields. These demands on reference terminology resulting from research applications will, in future, be merged with the evaluation results from patient treatment in order to allow a concerted approach to be taken.


Contact person at the TMF Office

Dr. Ulrich Gauger

Phone: +49 30 31 01 19 83

E-Mail

Products related to this topic

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



P101001 - Tools to integrate data in i2b2

P100801 - Primary database for microbiology data

P100101 - National Metadata Repository

P058011 - German Biobank Registry

P999021 - Hosting for SAE software

P042011 - Legal Opinion on electronic archiving

P021011 - SAS macros for clinical studies

P017021 - Informed Consent – Online-Assistent

P000011 - Pseudonymisation software

P024011 - Author portal for guideline development

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