The sponsor is responsible for ongoing safety evaluation, based on the IB or basic product information. It should aggregate and review relevant safety information in a timely way, including pre-dose events, updating the protocol, IB and consent materials as needed, and communicate promptly to participants, investigators, IRB/IEC and regulators any information that may affect willingness to continue, trial conduct or approvals. It should submit safety updates and periodic reports, including IB changes, as regulation requires; expedite reporting of SUSARs to regulators under regulation and ICH E2A, judging expectedness against the reference safety information (see ICH E2F); report SUSARs to investigators and IRBs/IECs in a way reflecting urgency and the evolving safety profile (periodic line listings may suit some regions); report urgent safety issues to the IRB/IEC, regulators and investigators without undue delay; agree any alternative reporting arrangements (for example endpoint SAEs not unblinded or expedited) in advance with regulators and, where relevant, the IRB/IEC and describe them in the protocol (see ICH E19); and act promptly on immediate hazards, determine their causes, take remedial action, consider protocol amendment and see that the hazard information and amendment are submitted.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.