The sponsor should manage quality throughout the trial with efficient protocols, tools and procedures, taking a proportionate, risk-based approach that designs quality in and identifies critical to quality factors, and describe the approach in the clinical trial report. It should identify risks with a meaningful impact on those factors before and during the trial across processes and systems (design, selection, consent, randomisation, blinding, product administration, data handling, providers); evaluate them by likelihood, detectability and impact on participant protection and result reliability; control them in proportion (for example through protocol design, monitoring plans, agreements and training) and, where relevant, set pre-specified acceptable ranges such as trial-level quality tolerance limits, evaluating exceedances for systemic issues; document and communicate risks and mitigations to those affected; review controls periodically for continued effectiveness; and summarise important quality issues, including exceeded ranges, and remedial actions in the clinical trial report.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.