SSArchivingDataManagement object

Study documents must be kept at least (in years)

10

Applicable national legal framework/ Reference

Art. 45 KlinV/ClinO;

Additional Information

Clinical trials with transplant products and blood products: at least 20 years (according to Art 40(1) TPA)

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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