Article 4 establishes the prior-authorisation requirement: every clinical trial must be subject to scientific and ethical review and authorised in accordance with the Regulation. Article 5 governs application submission via the EU portal (CTIS): the sponsor proposes a Reporting Member State and submits a single application dossier (Part I + Part II). The proposed Member State has 6 days to (a) accept itself as Reporting Member State or (b) inform the sponsor that another Member State has agreed to act as Reporting Member State; the validation phase runs for 10 days.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.