Final participant activities: end-of-study visits, transition to standard care, and unblinding

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The full CRC track covers 8 courses from study start-up to close-out — the skills sponsors actually look for.

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Eighteen months, and now this

The participant has been coming to the site every four weeks for a year and a half. She knows the parking garage, the elevator that sticks on the third floor, the coordinator who remembers that she prefers the blood draw from her left arm. She has tolerated the assessments, the questionnaires, the fasting labs, the occasional inconvenience of a schedule built around protocol windows rather than her own calendar. She has done this because someone -- the investigator, the coordinator, perhaps her own physician -- asked her to contribute to something larger than her own treatment. And she said yes.

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.