Updates from EMA on the Clinical Trial Portal and Database

ema-kCEH--258x258@Quotidiano_Sanita-WebEMA issued a press release regarding the 15 March EMA Management Board meeting. The following was noted in the press release regarding the Clinical Trial Portal and Database:

The Board received an update on progress with the development of the European Union (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 Board heard that 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 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.

Source: DIA – Clinical Trial Disclosure Community