Book series on telematics in medical research
Project results from the TMF and reference works on health telematics
In the spring of 2006, the TMF launched its own book series on telematics in medical research with the publication of the generic data protection concepts. The results from the TMF projects as well as reference works on telematics in medical research are published by the German medical scientific publishing company MWV. On publication of its results, the TMF, amongst other things, makes checklists, training documentation and legal expert opinions available, which are of substantial value for practical work in networked medical research projects.
The volumes of the TMF book series are only available in German language.
- More information on the German site
Volume 14: Communicating Health Research, Shaping Stakeholder Engagement
Basics, Practice, Trends
As society is increasingly moving towards more transparency and participation, communication processes in health research grow in importance. A trustful relationship between research organisations and their different stakeholders is key and needs to be cultivated continually.
This anthology provides expert experience and ideas about designing communication strategies and processes in health research. Aspects covered are strategy development, the relationship between science and media, providing evidence-based information for patients, issues of organisational communication, stakeholder engagement and fundraising.
This book mirrors the activities and trainings organised by the TMF working group science communication during the past couple of years. The working group is a forum to discuss the latest developments in science communication and organisational communication relevant to health research organisations.
W. Lesch | A. Schütt (Hrsg.)
Gesundheitsforschung kommunizieren, Stakeholder Engagement gestalten
Grundlagen, Praxistipps und Trends
1st edition, 210 pages, 32 figures, 2016
€ 49,95 [D], ISBN 978-3-95466-286-9
Volume 13: Terminology and Classification Systems in Medicine
The Current
Situation and Need for Action and Agreement in the German-Speaking World
Exchanging and utilising data across a broad variety of IT systems is a
necessity that creates considerable challenges for medical research and patient
care. Interoperability is key – for communicating data both accurately and understandably.
But to ensure IT systems consistently and correctly interpret the information
they receive, syntactic and semantic standardisation is essential. Against this
background, the 13th volume in the TMF book series, Terminologien und Ordnungssysteme in der Medizin − Standortbestimmung
und Handlungsbedarf in den deutschsprachigen Ländern (Terminology and Classification Systems in Medicine – The Current
Situation and Need for Action and Agreement in the German-Speaking World, available
in German only) investigates and compiles information on current terminology
usage in German-speaking (DACH) countries, with the goal of formulating a
standardised approach.
This edited
publication is the result of a pilot study on terminology and classification
systems funded by the German Federal Ministry of Health. A number of actors
from Germany, Austria and Switzerland (the DACH countries), took part in expert
workshops that used chosen scenarios (patient care summaries, medication
records and an electronic notification system for infectious diseases) to assess
terminology usage in the German-speaking world.
O. Rienhoff | S.C. Semler
(Hrsg.)
Terminologien und
Ordnungssysteme in der Medizin
Standortbestimmung und Handlungsbedarf in den
deutschsprachigen Ländern
1st edition, 221 pages, september
2015
€ 54,95 [D], ISBN
978-3-95466-136-7
Volume 12: Secondary Use of Clinical Data - Legal Framework
Research based on treatment data: a guide to the legal framework in Germany
Increasingly,
clinical data gained within the context of patient treatment is being harnessed
for research and quality assurance in healthcare. Systematic analysis of this
data offers new insights that would not be possible, or only with considerable
effort and expense, with data generated primarily for research alone. However,
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. TMF has published a guide that
describes in detail the legal framework for each specific situation. Moreover,
the hardcopy book is supported by an online tool that facilitates searches.
U. K. Schneider
Sekundärnutzung klinischer Daten - Rechtliche Rahmenbedingungen
mit einem Beitrag von A. Roßnagel und G. Hornung
1st edition, 418 pages, august 2015
€ 64,95 [D], ISBN 978-3-95466-142-8
Volume 11: Guideline for Data Protection in Medical Research Projects
TMF's generic solutions 2.0
Fostering medical progress and assuring high-quality treatments is no
longer possible without the long-term storage and analysis of clinical data and
biological samples. Against this background, sustainable data protection
concepts are becoming ever-more important. They are key to gaining the trust of
patients and donors – an essential element of medical research projects. For many
years, TMF’s generic data privacy concepts have formed a foundation for
planning and implementing projects involving the collection of data and
samples for long-term use in medical research projects. The documentation,
first published in 2003 and 2006 and approved by the association of data
protection officers, not only provides concrete solutions but also encourages dialogue
between researchers and data privacy experts. A common language and open
expression of both parties’ aims has led to significant shortening of approval
processes – saving time and effort for all those involved. TMF’s data protection work group has advised more
than 80 research projects on the design and implementation of data privacy
documentation and is, increasingly, a central point of contact for questions
relating to the topic. The new edited concepts draw on this rich experience.
They provide proven advice on the technical and organisational roll-out of data
protection principles. And thanks to their modular structure, they are now
suitable for a broader range of application scenarios.
K. Pommerening | J. Drepper | K. Helbing | T. Ganslandt
Leitfaden zum Datenschutz in medizinischen Forschungsprojekten
Generische Lösungen der TMF 2.0
1st edition, 240 pages, september 2014
€ 64,95 [D], ISBN 978-3-95466-123-7
Volume 4 (2nd edition): Data Quality in Medical Research
Guideline for adaptive management of data quality in cohort trials and registers
Drug trials, benefit analyses and
epidemiological trials play an important role in evidence-based decisions
within the healthcare system. Data is the foundation of all of these assets. And
the quality of this data is becoming increasingly important, not only to the
scientists themselves, but also in the politics of healthcare. TMF has
revised its guide to managing data quality in medical research, providing
up-to-date advice and assistance on the topic.
The publication defines a systematic approach to
managing data quality, provides a broad range of quality indicators and
highlights specific use cases. It is aimed at people responsible for data
management and quality assurance in cohort studies and registries as well as project
leaders. In addition, healthcare data and research based on clinical
evaluations can also be enhanced using the insights in the book.
M. Nonnemacher | D. Nasseh | J. Stausberg
Datenqualität in der medizinischen Forschung
Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern
2nd edition, 244 pages, september 2014
€ 64,95 [D], ISBN 978-3-95466-121-3
Volume 10: Informed Consent and Research Information to Obtain Animal Samples
Conducting research with animal samples on a sound legal basis
Infectious pathogens that are transmitted from animals to humans and can cause so-called zoonoses are the subject of numerous research projects. To be able to better understand, combat and monitor these pathogens, samples are taken from animals for the purpose of scientific investigations. In this field, legal and data protection issues arise which are the subject of the expertise. It was prepared on the initiative of the National Research Platform for Zoonoses and its purpose is to give researchers legal certainty for taking and processing animal samples, for compiling research information, and for obtaining informed consent declarations.
In order to sensitize researchers to the legal context in which they are operating the book explains what legal issues are involved in scientifically relevant sample-taking scenarios and in the further processing of data accompanying the samples. Topics range from the obligation to notify and report animal epidemics to the rights of use and exploitation in the samples.
At www.zoonosen.net there are also specimen texts concerning research information and informed consent declarations available for downloading free of charge.
J.W. Goebel | J. Scheller
Einwilligungserklärung und Forschungsinformation zur
Gewinnung tierischer Proben
1st edition, 200 pages, october 2012
€ 44,95 [D], ISBN 978-3-941468-95-5
Volume 9: Quality Management of High-Throughput Genotyping Data
Quality in high-throughput genotyping is feasible – practical recommendations for the processing and analysis of data
Genetic association studies have been performed with high-throughput methods relatively successfully for some time now. Such methods are based on the application of highly integrated, extremely powerful microarray technologies, which, however, involve a number of practical problems. Error sources result along the entire processing chain so the qualitative genotyping data generated is not completely reliable. Now that this book has been published there are widely agreed recommendations available on the quality assurance of data that is generated by high-throughput genotyping. The issues dealt with range from problems concerning validity and plausibility, identification and avoidance of errors, to requirements for data management and data transfer. The authors have systematically examined, compared and evaluated many different methods of processing and analyzing genotyping data with regard to quality aspects.In addition to the book, the TMF provides a software tool and various work materials that can be downloaded in the product area of the TMF website.
M. Krawczak | M. Freudigmann (Ed.)
Qualitätsmanagement von Hochdurchsatz-Genotypisierungsdaten
1st edition, 154 pages, december 2011
€ 39,95 [D], ISBN 978-3-941468-58-0
Volume 8: Regulatory Requirements for Medical Devices
Medical device development – introduction to and practical aids for handling the regulatory process
The development and placing on the market of medical devices are governed by a matrix of legal regulations and standards. These rules stipulate what development phases are necessary and what objective evidence documents have to be produced with regard to the suitability, safety, and performance of the product if it is to be tested on human beings and ultimately brought into circulation.The book provides an introduction to the regulatory framework concerning medical device development and explains concisely the relevant regulatory terms such as clinical evaluation, clinical trial, clinical studies, and Health Technology Assessment. The terms must be internalized by all the parties involved and be accorded the same level of attention in the development process as the purely technical and medical product requirements from the viewpoint of users or the market.
In this book, medical device developers will find support for regulatory classification of their products and definition of the necessary development steps, depending on the relevant risk class and intended use. Along the entire process chain the book provides practical aids in the form of checklists, decision trees, Reporting Guidelines, and SOP lists with commentaries.
R. Mildner (Ed.)
Regulatorische Anforderungen an Medizinprodukte
Einführung und
Handlungshilfen - von klinischer Bewertung bis HTA
1st edition, 154 pages, december 2011
€ 39,95 [D], ISBN 978-3-941468-29-0
Volume 7: Utilization Rights in Networked Medical Research
Legal expert opinion on value creation from the exchange of data between medical care and research
Patient care and medical research are constantly generating knowledge, data, results, services, and products, the value of which is often difficult to estimate. Data from patient care is made available for research just as, vice versa, results of medical research are incorporated in patient care.Mutual data transfer is impaired not only by differing data standards and often non-standardized IT infrastructures but also by unclarified legal issues. Consequently, it is often not clear whether results are legally protected, what regulations apply to them, which persons involved hold the various rights, and how the latter can be transferred.This expert opinion examines the value creation process in which added value is created at various stages with considerable effort and input of resources. In this context the focus is on utilization law issues, while data protection law issues are dealt with in numerous other TMF publications.This volume in the TMF book series systematically presents potentially protected objects, such as individual items of data, data collections, studies, computer software, or inventions, and the various protection concepts, ranging from copyright law to contract law. The authors explain in detail issues that are encountered by involved patients, doctors, and research networks. They integrate the conclusions into specific recommendations and information about how to draft contracts. The book is rounded off by specimen contracts.
J. W. Goebel | J. Scheller
Verwertungsrechte in der vernetzten medizinischen Forschung
Rechtsgutachten zur Wertschöpfung beim Datenaustausch zwischen medizinischer Versorgung und Forschung
1st edition, 172 pages, december 2008
€ 39,95 [D], ISBN 978-3-939069-99-7
Volume 5: Biobanking
Quality assurance checklist
Biobanking is regarded as a much sought-after international key resource for research on the complex molecular mechanisms involved in the pathophysiology of diseases with hereditary components. In order to ensure that these valuable material collections can be used by the science community in the long term, general guidelines on organization and quality assurance for biobanking establishment and operation were developed within the TMF as part of a comprehensive biobanking project.
Following the publication in 2006 of a legal expert opinion on biobanking development and operation, the fifth volume of the TMF book series now provides the research community with an implementation guide that assists the user in both the development of a new quality management system and the customization of an existing system.
M. Kiehntopf | K. Böer
Biomaterialbanken – Checkliste zur Qualitätssicherung
under collaboration of J. Goebel
1st edition, 201 pages, february 2008
€ 49,95 [D], ISBN 978-3-939069-56-0
Volume 4: Data quality in medical research
Guideline for adaptive management of data quality in cohort trials and registers
The value of disease-related scientific cohort trials and registers as developed by medical competence networks and other medical research networks depends, for the most part, on the quality of the data they record. However, determining the quality of data in cohort trials and registers is far from easy and is therefore often not precisely known.
This guideline contains recommendations on managing the data quality of registers and cohort trials. Quality indicators are described and made available for these checklists. As such, it is an important part of the varied expedient measures for improving and assuring the quality of data in medical research.
M. Nonnemacher | D. Weiland | J. Stausberg
Datenqualität in der medizinischen Forschung
Leitlinie zum adaptiven Management von Datenqualität in Kohortenstudien und Registern
1st edition, 228 pages, april 2007
€ 49,95 [D], ISBN 978-3-939069-36-2
Volume 3: Checklist and guidelines on informed consent
Informed consent – practical support for clinical researchers
A key component in ensuring the legal certainty of the collection, processing and use of pseudonymized patient data in trials and research projects is informed consent. This, in turn, places great demands on the information content and unambiguous documentation of the patient’s consent with respect to the particular project. When drawing up patient information and declarations of informed consent, medical, ethical and statutory data protection requirements must be met.
The third volume in the TMF book series is a work of reference that enables users to develop patient information and declarations of informed consent on the basis of relevant, documented and commented sources that meet regulatory requirements.
U. Harnischmacher | P. Ihle | B. Berger | J. W. Goebel | J. Scheller
Checkliste und Leitfaden zur Patienteneinwilligung
Grundlagen und Anleitung für die klinische Forschung
1st edition, 176 pages, december 2006
€ 44,95 [D], € 46,30 [A], SFR 78.00,
ISBN 978-3-939069-25-6
Volume 2: Biobanking – legal framework
Preventing uncontrolled growth and facilitating long-term use
Large-scale development and operation of biobanking is becoming increasingly important: material banks that make samples available for medical scientific analysis in the long term, offer major potential for clarifying pressing medical research issues. This is particularly true if the samples are merged with data on the progress of the disease in individual patients.
Increased networking in the field of biomedical research is leading to the creation of comprehensive data and sample collections. This, however, poses numerous legal and organizational questions for which in Germany there are no clear regulations to date. The TMF picked up these issues and provided answers to many questions in an interdisciplinary project. These answers were been made available to researchers in the form of action checklists and specimen texts. This second volume of the TMF book series examines the legal framework for biobanking development and operation from a juridical perspective.
J. W. Simon | R. Paslack | J. Robienski | J. W. Goebel | M. Krawczak
Biomaterialbanken – Rechtliche Rahmenbedingungen
1st edition, 240 pages, september 2006
€ 69,95 [D], ISBN 978-3-939069-14-0
Volume 1: Generic data protection solutions for medical research networks
Data protection and medical research are compatible
One of the biggest challenges faced by medical research is conducting clinical trials on large patient groups over lengthy periods of time. The strict data protection legislation in Germany that has evolved over the course of time frequently does not allow the pooling of patient-related data, which is necessary in this context.
The TMF’s "Generic data protection solutions for medical research networks" help negotiate a major hurdle in the field of medical scientific cooperation. They make it possible to sustainably optimize a flow of information from the hospital to the scientific world and from here to patient care. Their application means that no expensive specially developed structures are required for ensuring data protection.
C.-M. Reng | P. Debold | Ch. Specker | K. Pommerening
Generische Lösungen zum Datenschutz
für die Forschungsnetze in der Medizin
1st edition, 120 pages, march 2006
€ 39,95 [D], ISBN 987-3-939069-04-1