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  4. Guidelines on Data Protection in Medical Research Projects
Guideline

Guidelines on Data Protection in Medical Research Projects

The TMF's Generic Solutions 2.0

Download [in German]: Open Access Version

Ethik & Datenschutz
Das Cover von Band 11 der TMF-Schriftenreihe

© Mockup designed by anthonyboyd / Freepik

The trust of patients and test subjects is an essential prerequisite for the success of medical research projects, which can only be carried out with the collection, long-term storage, and analysis of clinical data and specimens. Medical research today is predominantly networked in increasingly large research networks. Accordingly, the importance of data protection and data security continues to grow. The TMF first developed generic data protection concepts for medical research networks in 2003, coordinated them with the federal and state data protection officers, and made them available to the research community. This enabled numerous research projects to develop and coordinate their data protection concepts more quickly - also with the advice of the TMF's Data Protection Workgroup. The insights gained in the process have been incorporated into the current fundamental revision of the generic concepts. The new concept takes into account the complexity of medical research processes through a modular establishment and has also been embedded in a comprehensive guideline. The new concept was also discussed in detail with data protection experts and is recommended by the Conference of Federal and State Data Protection Commissioners as a basis for concretely developing data protection concepts for medical research projects and consortia.

 

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

 

Copyright and license conditions for this product (No. P000022)

This work, including all its parts, is protected by copyright. Unless otherwise stated, the rights are held by the TMF. TMF cannot guarantee the accuracy of the contents. Reproduction and forwarding are only permitted within your organization or company and the TMF membership unless otherwise agreed with the TMF. For quality assurance and transparency regarding the dissemination and use of TMF results, further dissemination occurs exclusively via the TMF website or the TMF office.

This work was conceived as working material, which is why changes may be made to printouts and renamed copies of the original file, provided they are appropriately labeled to avoid confusion with the original document. The terms of use and the TMF logo may be removed from the modified copies. The TMF recommends always keeping the printed original document or the read-only original file as a reference. Reproduction and forwarding of modified versions are also only permitted within your organization or company and the TMF membership unless otherwise agreed upon with the TMF.

If modified copies or documents created by you with the help of this work are used in practice, they should be sent to the TMF office via email (info@tmf ev.de) unless legal or contractual regulations (also regarding third parties) prevent this. These documents will be used by the TMF exclusively for further development and improvement of TMF results and will not be published.

Downloads [in German]

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