Development of the Clinical Trials Information System
EMA continues to regularly engage with external stakeholders on CTIS development and change management matters, before and after go-live, under the stakeholder engagement model in place since 2019.
Nominated experts representing national competent authorities, ethics committees, clinical trial sponsors, healthcare professionals, patients and the general public were able to test, review, select and verify CTIS functionalities.
During development, EMA consulted EU Member States, the European Commission and stakeholders representing clinical-trial sponsors (including micro, small and medium-sized enterprises (SMEs) and academic organisations), healthcare professionals and patient groups on its proposals, including on:
- the draft functional specifications in 2014;
- implementing the transparency rules in 2015.
More background information is available in the documents below.
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