New Eudralex Vol.10 Guidance

The EU Commission has published a technical guidance on the format of the data fields of result-related information on clinical trials submitted in accordance with Article 57(2) of Regulation (EC) No 726/2004 and Article 41(2) of Regulation (EC) No 1901/2006. It It provides a visual representation of the clinical trial results data that is required to be captured by EudraCT. It also provides details of how the fields are organised.


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