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Submission instruction ordering biobank information letters and consent forms in a release file

In order to assess whether the donor’s consent covers the proposed research, it is important that all versions of the information letters and consent forms under which consent was obtained are submitted. 

Over time, multiple versions may have been used. In addition, material and data from multiple sources (e.g. a biobank and residual material of a research study) or different types of donors (e.g. adult donors and children) may be included in the study. In order to create a clear overview of the file, starting today it is necessary to organize the biobank information letters and consent forms in a logical manner according to a predetermined format.  

Read more on Use of human biological material (release review), File

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