Procedural Rules of a National Hemophilia Register in Germany

Procedural Rules of a National Hemophilia Register in Germany

R. Zimmermann, H.-H. Brackmann, M. von Depka Prondzinski, H. Lenk, W. Schramm, I. Scharrer and Members of the Medical Advisory Council of the German Hemophilia Association (DHG)

The Medical Advisory Council of the German Hemophilia Association (DHG), the supervisory Board of the Hemophilia Commission of the GTH, the managing Board of the DHG as well as the political committees demand the institution of a register of the patients with hemophilia and other hemorrhagic diatheses. Consequently, the medical Advisory Council of the German Hemophilia Association and the Hemophilia Commission of the GTH have set themselves the task to compile a national hemophilia register. A set of procedural rules has been formulated as the basis for the collection, central storage, processing, evaluation and publication of data. The activities for creating such a register are aimed at the following objectives:

Production and care of a register of patients with hemophilia and other hemorr- hagic diatheses in Germany; to create the conditions for establishing such a register, especially in terms of data privacy and data security; Presentation of the data and publication of important aspects to provide an incentive for the planning of multi- center studies; to raise funds for the care of the hemophilia register; Promotion of the cooperation among the hemophilia centers; solution of clinical and health- policy problems as well as to optimize patient care.

The procedural rules define the organs such as the Steering Committee and the Data Safety and Monitoring Committee. Appendix I of the agenda describes the rules for publication. Appendix II sets forth the utilization of the data. In Appendix III, all of the participants involved in establishing the hemophilia register have to declare their consent to the procedural rules by giving their signatures. Appendix IV provides an in-depth explanation of the data processing and the data privacy and security. In another appendix, the patients are informed about the objectives of the hemophilia register and about data privacy and security; in addition the agenda contains a proposal for the patients informed consent.

Medical Advisory Council of the German Hemophilia Association:

K.-H. Auerswald, H.-H. Brackmann, M. von Depka Prondzinski, B. Eifrig, L. Gürtler, C. Heinrichs, F.H. Herrmann, L. Hovy, W. Kreuz, K. Kurnik, H. Lenk, H. Pollmann, I.

Scharrer, G. Syrbe, H.-H. Wolf, R. Zimmermann. Assessors: M. Siller, W. Kalnins.

I. Scharrer/W. Schramm (Ed.)

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Hemophilia Symposium Hamburg 2003

” Springer Medizin Verlag Heidelberg 2005