Status of EU clinical trial portal and database March 2018

Status of EU clinical trial portal and database March 2018

At its meeting in London, UK, March 2018, the EMA Management Board was informed about progress in the development of the EU portal and database.

Based on the experience with this complex development so far, the developer has submitted a revised project plan with improved project management, development and testing processes and resources. It also contains increased contingency.

The first item (release 0.6) due under that plan has been received and has met the acceptance criteria. Further experience will enable greater confidence in the plan to be gained and an external party will also be asked to review this and report to the EMA Management Board. The plan shows that release 0.7 should be available for audit, as required by Article 82 of the Clinical Trial Regulation, early in 2019. More precise information on timelines will be communicated after the audit.

Reference:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2018/03/news_detail_002923.jsp&mid=WC0b01ac058004d5c1

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