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List of submitted documentation for Part II

In connection with the increased number of clinical trials submitted this year and the increasing number of requests for corrections of decisions, we ask sponsors to submit separate document together with a documentation (template is published below the article), which will include the following requirements:


• EUCT number (or other kind of CT identification)

• List of submitted documentation

• Actual version and current date of the document


May 24, 2024

Department of Clinical Trials on Pharmaceuticals


doc.pngN1_List of Documents_san.docx, soubor typu docx, (12.97 kB)