Article 8 sets the decision regime. Each Member State concerned notifies the sponsor through CTIS whether the trial is (a) authorised, (b) authorised subject to conditions, or (c) refused. Refusal is possible only on the specified grounds (Part I disagreement with Reporting Member State conclusions; Part II grounds incl. national-law incompatibility, subject-safety risks, etc.). The decision is final at Member State level, subject to national appeal procedures.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.