P101201 - Survey and recommendations for the German-speaking countries
Contact Person:
P101102 - Interactive tool to identify relevant legal bases for secondary use of clinical data in Germany
This tool
complements the guide to the legal framework for secondary use of clinical data
in Germany and facilitates searches for the relevant legal bases according to
the location and type of facility involved.
Contact Person:
P101101 - Publication in the TMF book series
Product No P101101
The
legislation governing secondary use in Germany is extremely complex, and can
vary significantly depending upon the location and type of facility involved,
and the purpose of usage. This guide describes in detail the legal framework
for each specific situation. Moreover, the hardcopy book is supported by an
online tool that facilitates searches.
Contact Person:
P101001 - Tools to integrate data in i2b2
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.
Contact Person:
P100901 - Descriptions of IT requirements for cohorts and registers
From evaluation to consolidation: Specification of requirements on cohort studies and register-IT
Umfassender und an die jeweiligen Gegebenheiten anpassbarer Anforderungskatalog für IT-Lösungen bei Kohorten und Registern. Im Anforderungskatalog, der als Excel-Datei bereitgestellt wird, werden Top-Level-Aufgaben und Use Cases (Anwendungsfälle) mit ihren Bezeichnungen tabellarisch aufgeführt. Die Spezifikation, die sowohl als PDF-Datei sowie auch als bearbeitbare Word-Datei vorliegt, beschreibt jeden Anwendungsfall in einem strukturierten Format (Unified Modeling Language). Anforderungskatalog und Spezifikation in Version 0.9 enthalten 44 Top-Level-Aufgaben und 203 Use Cases.
A comprehensive and to particular circumstances customizable statement of requirements for IT solutions in cohorts and registers. In the statement of requirements, provided as an Excel file, top-level tasks and use cases are tabulated with their terms. The specification, which is present as a PDF file as well as an editable Word file, describes each application in a structured format (Unified Modeling Language). Statement of requirements and specification in version 0.9 include 44 top-level tasks and 203 use cases.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100500 - IT infrastructures in patient-centric research
Annual report of the TMF IT Review Board: current
status and future requirements
For many years, medical research focussed on selecting
or programming individual IT applications. Today, however, it is necessary to
develop end-to-end concepts that integrate diverse infrastructure components
into the overall IT landscape of a research institute or association. These
components range from databases and software applications to robotics control
systems and support for mobile communication. A key prerequisite for
integration and further development of solutions is an on-going analysis of the
current situation and future requirements. To this end, in 2013, TMF’s IT
Review Board published its first annual report on this topic.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100401 - Architecture for patient recruitment from hospital information systems (HIS)
Concept and architecture for the use of HIS data for
patient recruitment in clinical trials
This architecture for
HIS-based support for patient recruitment in clinical trials was developed by
researchers from five university hospitals, with TMF acting as project
coordinator. The research teams implemented the solution as a prototype and evaluated
its performance, in particular as regards implementation effort and the concrete
benefits for patient recruitment. It was possible to create and successfully
deploy a similar e-recruitment solution for use with all common German HIS
systems. The concept has been made publicly available, and contacts at each of
the five locations are available to advise interested parties at other
locations regarding the HIS used at their respective facilities.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100101 - National Metadata Repository
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.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P039031 - Legal Opinion on data protection in medical research
Legal Opinion on data protection in medical research, in particular concer-ning the duty of pseudonymisation according to the German Medicinal Products Act (‚AMG‘), the use of health care data as well as the electronic health card, and the relevance of the German Act on Medical Devices (‚MPG‘)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail