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EU database for clinical trials


Public consultation of the "draft functional specifications for the EU portal and EU database to be audited" to Stakeholders by October 31


In light of the new Clinical Trial Regulation, the EMA is in charge of creating the EU portal and the EU database for clinical trials, which are intended to simplify and harmonise the submission, assessment and reporting of clinical trials.  

A draft of the functional specifications for the EU portal and EU database to be audited is now published on the EMA web site for a 3 weeks public consultation (see this pdf). Comments on this document should be sent to GCP@ema.europa.eu using the template (word document) by 31st October 2014.