P101401 - ToolPool Health Research
ToolPool Health Research: A portal for IT tools und information. From researchers for researchers.
Inger Neick
TMF Office
+49 30 22 00 24 732
E-MailContact Person:
P101201 - Survey and recommendations for the German-speaking countries
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
P100801 - Primary database for microbiology data
Primary database for standardised storage of
microbiology data
This software makes
it possible to store microbiology data based on standardised criteria, simplifying
the transfer of data within an institute and between research partners working
in the same area. The data categories were defined by researchers and
programmers from various disciplines of microbiology research. The software
package is accompanied by a comprehensive user guide.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100701 - Phase II package
R package and software tool
for planning, monitoring and evaluating phase II oncology trials
This validated R
package and user-friendly software tool support planning, statistical
monitoring, and evaluation of phase II oncology trials – enabling biometricians
performing research in this field to create designs tailored to each individual
study, to closely monitor proceedings over the course of the trial, and to leverage
valid and efficient analysis methods for evaluation.
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
P100301 - R-Program package for optimisation and flexible adaptation of multi-stage designs for genome-wide association studies
Package supporting flexible planning of genetic
epidemiology studies
This package provides
multi-stage designs for genome-wide association studies (GWAS). Over the course
of the study or genotyping process, the solution makes it possible to progressively
reduce marker sets to those markers that are most promising. The goal is to
minimise the cost of genotyping or of the overall study, to maximise study results
even if budgets are tight, and to unlock the full potential of the technology
when genotyping an existing sample. Moreover, a process based on the CRC
principle generates interim results to enable users to flexibly select markers
for the next stage, without being restricted to formal criteria (critical
limits for p-values). And if necessary, this process also makes it possible to
re-define the subsequent number of cases. The program package (R system) is an
intuitive solution that supports statistical calculations based on these
methods, without requiring users to do any programming themselves. In addition,
it will be available at a later date via the Comprehensive R Archive Network
(CRAN), as a component of the R software.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100201 - Software prevent the re-identification
Not in all research projects is it possible to
rule out re-identification of individuals or samples by anonymization, i.e.
deleting the identifiers. Assuming appropriate additional knowledge is
available, sensitive health-related information can possibly also be retrieved
from anonymous databases. The Anon Tool helps avoiding this by coarsening the medical
data by means of k-anonymization and l-diversity.
Contact Person:
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
P042041 - Expert Opinion on economic aspects of electronic archiving
Expert Opinion costs and benefits of archiving strategies for clincial trial documents
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P042031 - Expert Opinion on the use of CDISC-ODM for electronic archiving
Expert Opinion on the pros and cons of CDISC-ODM for archiving of clinical trial data
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P042021 - Expert Opinion on conventional file formats for electronic archiving
Expert opinion on the applicability of conventional file formats for electronic archiviung in clincial trials
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P999112 - Narrative script for pharmacovigilance software
Script supporting the generation of case narratives for CIOMS reports required for the management of SAEs using VigilanceONE
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P999111 - Report templates for pharmakovigilance software
Templates for generating reports and submission forms for the management of SAEs using VigilanceONE
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P014012 - Software library for data protection concept (model A)
Library for developing client and server software for the implemetation of generic data protection concept, model A (provided by the Department of Medical Informatics at University of Mainz)
License and Copyright
The software is published under MIT-License:
Copyright (c) 2010 René Brüntrup, Martin Lablans, Frank Ückert
Permission is hereby granted, free of charge, to any person obtaining a copy of this software and associated documentation files (the "Software"), to deal in the Software without restriction, including without limitation the rights to use, copy, modify, merge, publish, distribute, sublicense, and/or sell copies of the Software, and to permit persons to whom the Software is furnished to do so, subject to the following conditions:
The above copyright notice and this permission notice shall be included in all copies or substantial portions of the Software.
THE SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS OR COPYRIGHT HOLDERS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY, WHETHER IN AN ACTION OF CONTRACT, TORT OR OTHERWISE, ARISING FROM, OUT OF OR IN CONNECTION WITH THE SOFTWARE OR THE USE OR OTHER DEALINGS IN THE SOFTWARE.
Downloads
- Documentation (german) [pdf]
- Data Protection Library Version 1.0.2 [zip]
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
Contact - University of Mainz
Department of Medical Informatics
Johannes Gutenberg-Universität Mainz
Obere Zahlbacher Str. 69
D 55131 Mainz
Germany
Phone: +49 (0) 6131 17 - 3252
P999071 - Specimen contracts - Contracted software developement and cession of utilisation rights
Specimen contracts for the assignment of contracted software development, cession of software and online databases and the formulation of non-disclosure agreements
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P999031 - Licence granting for SAE software
Voucher to call up licenses for the SAE management software VigilanceONE on special terms
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P999021 - Hosting for SAE software
TMF
hosting service for the use of SAE management software VigilanceONE via
remote access (ASP)
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P052012 - Specimen Contract for data custodianship
Checklist and specimen contract for data custodianship in networked medical research
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P052011 - Legal Opinion on data custodianship
Legal Opinion on data custodianship in networked medical research
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P042011 - Legal Opinion on electronic archiving
Legal opinion on electronic storage of documents and data files in the context of clinical trials
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P034011 - SDTM converter
Software for the transformation of clinical data from CDISC-ODM structures to SDTM format
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P021011 - SAS macros for clinical studies
TMF macro collection for the SAS software for the evaluation of clinical studies
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P019013 - System validation – Training documentation
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P019012 - Audit concepts for computer systems
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P019011 - System validation master plan
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P015011 - PID generator
Software component for the creation and error-tolerant matching of first-order pseudonyms on the basis of identifying patient data
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P000011 - Pseudonymisation software
Software for the use of a specialized TMF IT infrastructure for the symmetrical encryption of single-level pseudonyms
Software for two-stage pseudonymization of medical data for the development of research databases that can be used in the long term. Available since the end of 2009 following reconceptualization and reimplementation. In conjunction with tools for the administration of single-level pseudonyms it enables data protection-compliant development of new kinds of research databases with long-term merging of follow-up data sets and person-related feedback of research results.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail