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.
- Contact and order information on the German site
Volume 7: Rights of utilization
Legal opinion
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
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.
Kiehntopf | 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.
Nonnemacher | Weiland | 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.
Harnischmacher | Ihle | Berger | Goebel | Scheller
Checkliste und Leitfaden zur Patienteneinwilligung
Grundlagen und Anleitung für die klinische Forschung
1st edition, december 2006
Softcover, 176 pages
€ 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.
Simon | Paslack | Robienski | Goebel | 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.
Reng | Debold | Specker | Pommerening
Generische Lösungen zum Datenschutz
für die Forschungsnetze in der Medizin
120 pages, march 2006
€ 39,95 [D]
ISBN 987-3-939069-04-1