Now the study is ending. Her last protocol-required visit is approaching. And the question that confronts the research team is deceptively simple: what does the site owe this person at the end?

The answer, I would argue, is more than most sites deliver. The end-of-study visit is not merely the last line on a visit schedule. It is the final act of the ethical relationship between the research enterprise and the individual who made that enterprise possible. It is the moment where the promises made during informed consent -- that the participant would be told about the study's findings, that the transition back to standard care would be managed responsibly, that the research team would not simply vanish -- must be honored.

ICH E6(R3) codifies some of these obligations explicitly. But the best coordinators I have observed go beyond the regulatory minimum. They treat the end-of-study visit as a bridge -- not a cliff -- between participation and the participant's ongoing medical care.

This lesson covers the three components of that bridge: the end-of-study visit itself, the transition to standard care, and the unblinding process when applicable.

Now the study is ending. Her last protocol-required visit is approaching. And the question that confronts the research team is deceptively simple: what does the site owe this person at the end?

The answer, I would argue, is more than most sites deliver. The end-of-study visit is not merely the last line on a visit schedule. It is the final act of the ethical relationship between the research enterprise and the individual who made that enterprise possible. It is the moment where the promises made during informed consent -- that the participant would be told about the study's findings, that the transition back to standard care would be managed responsibly, that the research team would not simply vanish -- must be honored.

ICH E6(R3) codifies some of these obligations explicitly. But the best coordinators I have observed go beyond the regulatory minimum. They treat the end-of-study visit as a bridge -- not a cliff -- between participation and the participant's ongoing medical care.

This lesson covers the three components of that bridge: the end-of-study visit itself, the transition to standard care, and the unblinding process when applicable.