Clinical Trial Regulation: update
17 juin 2019
EMA has revised the Clinical Trial Information System (CTIS) project methodology and plan to improve delivery. Member States and stakeholders are now directly engaged in the development of CTIS through nominated ‘product owners’ to ensure that their expectations are taken into account. This means that business expert representatives have an enhanced and continuous opportunity to review, select and verify functionalities.
The codes of the EU Clinical Trial Portal and Database and the safety reporting module have been merged and safety reporting functionalities have been developed.
In June 2019, CTIS enters a phase of agile, iterative delivery, to prepare the system for audit. It will then be further enhanced for go-live and beyond, in close cooperation with the user community.
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