2012-04-12 European Commission - Questions & Answers Document
The European Commission has published a revised Questions and Answers document regarding clinical trials.
see: VOLUME 10 - GUIDANCE DOCUMENTS APPLYING TO CLINICAL TRIALS, Questions and Answers Version 10.0.
When conducting a clinical trial in Europe a lot of regulations have to be considered. Although there is a consistent standard (e.g. concerning clinical trials with medicinal products) there still remain many differences between the member states.
This database should provide a valuable source of advice to people who are involved in the planning of mono- or multi-centre clinical trials within different European countries. It contains contact addresses of national authorities as well as national legislation and documents.
The TREAT-NMD Regulatory Affairs Database has been developed by the Clinical Trials Unit of the University Medical Center Freiburg within the TREAT-NMD Network. In co-operation with the European Clinical Research Infrastructures Network (ECRIN) information provided in this database is updated on a regular basis (at least once a year).
(For more information please click on one of the country items below)
Additional information is available about
Please note:National and international regulations or legislation in the field of clinical trials are subject to continuous amendments. In spite of careful verification, liability for the correctness, completeness, and up-to-dateness can not be assumed. The information provided represents the authors' opinions, without making claims to their correctness or agreement with regulations, legislation or official use.
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Please do not hesitate to contact us by Email: treatnmd.regaffairs@uniklinik-freiburg.de