Article 48 requires the sponsor to monitor the conduct of the trial in order to verify that the rights, safety and well-being of subjects are protected, that reported data are reliable and robust, and that the trial is conducted in accordance with the protocol, GCP and applicable Union law. The extent and nature of monitoring is determined by the sponsor based on a risk-based approach taking into account the characteristics of the trial (the risk-based monitoring principle, aligned with ICH E6(R3) A1.7).
This control maps to 2 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.
Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.
The graph holds this control, the 2 it maps to, and the evidence behind each claim, over MCP and REST.