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.

Source: http://ec.europa.eu/health/files/eudralex/vol-10/2013_01_22_tg_en.pdf