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.
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:
P000022 - Generic Data Concepts 2.0
Guide to data protection in medical research
projects: TMF’s generic solutions 2.0.
TMF’s new generic data protection concepts were
published as a book in 2014. As with the original edition from 2003, this
updated publication was written in close collaboration with leading data
protection experts. As a result, the German association of government data
protection officers at national and federal state level has recommended the
guide to medical research projects and cross-facility teams who are looking to
develop their own data privacy documentation. The new concept offers a modular
structure designed to support the complex nature of medical research processes,
and it has now also been published as part of a comprehensive guide.
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P100601 -
J.W. Goebel | J. Scheller
Einwilligungserklärung und Forschungsinformation
zur Gewinnung tierischer Proben
TMF Book Series Volume 10, 200 pages, October 2012
€ 44,95 [D], ISBN 978-3-941468-95-5
Contact Person:
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:
P075011 - Training Documents on Medical Device Regulation
Training documents on regulatory requirements for clinical evaluation and clinical trials with medical devices
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
P062011 - Clinical Evaluation, Clinical Studies and HTA for Medical Devices
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P010211 - BMB Co-operation in the EU
Summarised expert opinions and generic texts for German biobanks in EU-wide co-operation projects
Contact Person:
Dr. Johannes Drepper
TMF Office
Tel.: +49 30 22 00 24 740
E-Mail
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
P999061 - Expert Opinion on Biobanking in Germany
P999051 - Assessment of data protection concepts
Consultation on the creation and implementation of data protection con-cepts based on TMF generic data protection concepts by the TMF „Data Protection“ working group
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
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
P022022 - Specimen Texts for matters of exploitation
Information and specimen texts on drafting of contracts when transfering knowledge and data between medical research and health care
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P022021 - Legal Opinion on rights of utilisation
Goebel J, Scheller J: Rights of utilisation in networked medical research - Legal opinion on value creation by transfering and processing data in medical research and health care, Berlin 2009 (TMF book series, vol. 7)
Contact Person:
Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P017031 - Informed Consent - Checklist
Checklist for the compilation of informed consent material
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P017021 - Informed Consent – Online-Assistent
Software assistant for web-based use of the TMF checklist for creation of patient information and informed consent
Contact Person:
Dr. Johannes Drepper
TMF Office
+49 30 22 00 24 740
E-Mail
P017011 - Informed Consent – Guideline
Harnischmacher U, Ihle P, Berger B, Goebel J, Scheller J: TMF checklist and guidelines on informed consent. Fundamentals and guidance for clinical research, Berlin 2006 (TMF book series, vol. 3)
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
P010021 - Data Protection Concept for Biobanking
Pommerening K, Hummel M, Ihle P, Semler SC: Biobanking – Data protection and ethical aspects, Berlin 2008 (TMF series of publications, vol. 6)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P010012 - Specimen Contracts for Biobanking
Specimen TMF texts and contracts for the development and operation of biobanks
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
E-Mail
P010011 - Legal Opinion on Biobanking
Simon JW, Paslack R, Robienski J, Goebel JW, Krawczak M: Biobanking – Legal framework, Berlin 2006 (TMF book series, vol. 2)
Contact Person:
Sebastian C. Semler
TMF Office
+49 30 22 00 24 710
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