June 2019: EudraCT Regulatory Update

List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 1901/2006 and its implementing guideline 2009/C28/01: Version 2.0

Version 2.0 of the list of fields to be made public from EudraCT for paediatric clinical trials 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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