Quality, meaning fitness for purpose, should be designed into how the trial is scientifically and operationally planned and run. The attributes that are fundamental to protecting participants, to reliable and interpretable results and to decisions based on them should be identified in advance, with quality by design concentrating on them, and strategies should exist to avoid serious noncompliance with GCP, the protocol and regulation, and to detect, address and stop it recurring.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.