The sponsor should establish, implement and maintain QA and QC processes and documented procedures so trials and data meet the protocol, GCP and regulation. QA applies throughout the trial using risk-based strategies to find what could cause, or is causing, serious noncompliance for corrective and preventive action. Audits, independent of monitoring and QC, evaluate whether trial processes ensure compliance; when done they should be proportionate to risk, carried out by people independent of what they audit and qualified by training and experience, follow documented procedures on scope, method (on-site or remote), frequency and report content, be planned according to factors such as the trial's regulatory importance, size, complexity, risk and known problems, and have findings documented. Regulators should not routinely request audit reports (only case by case, such as suspected serious noncompliance or legal proceedings), and the sponsor should give an audit certificate where regulation requires.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.