I have observed that sites often prepare meticulously for enrollment but give far less attention to how participation ends. This is a mistake. The manner in which a site handles discontinuation and withdrawal determines whether the data collected remain usable and whether participants continue to receive appropriate care. Meanwhile, investigational product accountability—the ability to trace every unit from receipt to final disposition—is not a bureaucratic exercise. It protects participants from receiving compromised product and protects the trial from questions about whether the right product reached the right people.

Sections 2.9 and 2.10 of ICH E6(R3) Annex 1 address these paired concerns: what happens when participation ends, and how investigational product must be managed at the site. Together, they ensure that trials end as responsibly as they begin.

I have observed that sites often prepare meticulously for enrollment but give far less attention to how participation ends. This is a mistake. The manner in which a site handles discontinuation and withdrawal determines whether the data collected remain usable and whether participants continue to receive appropriate care. Meanwhile, investigational product accountability—the ability to trace every unit from receipt to final disposition—is not a bureaucratic exercise. It protects participants from receiving compromised product and protects the trial from questions about whether the right product reached the right people.

Sections 2.9 and 2.10 of ICH E6(R3) Annex 1 address these paired concerns: what happens when participation ends, and how investigational product must be managed at the site. Together, they ensure that trials end as responsibly as they begin.