ICH E6(R3) - Good Clinical Practice 2.7: Keep a qualified physician or dentist responsible for trial medical care, provide adequate care for trial-related adverse events, inform the primary physician with consent, report protocol-required events to the sponsor and all SAEs immediately with causality, and supply follow-up on deaths

What does 2.7 require?

A qualified physician or dentist (or other qualified professional allowed locally) who is an investigator or sub-investigator should be responsible for medical care and decisions arising from the trial, with other qualified professionals involved in line with their normal roles. During and after participation the investigator or institution should ensure adequate care for adverse events related to the trial, clinically significant lab results included, tell participants when they need care for intercurrent illness the investigator learns of, and inform the participant's primary physician, where there is one and the participant agrees. Adverse events and abnormal results the protocol requires should go to the sponsor as and when the protocol specifies (including pre-dose events if required); every serious adverse event should be reported to the sponsor immediately once the investigator is reasonably aware, with a causality assessment and follow-up reports, unless the protocol lawfully exempts some (such as endpoint events); for deaths, any extra information requested (for example autopsy or terminal medical reports) should be supplied to the sponsor, IRB/IEC and regulators as applicable. Safety reporting may be delegated, but responsibility stays with the investigator.