June 2019: EudraCT Regulatory Update

List of fields contained in the “EudraCT” clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/C168/02: Version 2.0

Version 2.0 of the list of fields in the EudraCT clinical trials database to be made public is published. Version 1.0 of the document which was published in February 2009 has been revised to harmonize the title of the fields with the “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”.

According to the recent version, additional data fields related to the Age Range of trial subjects will be made publicly available in the European Clinical Trials Register (EU CTR).

The version 2.0 of the document is available here.

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