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Module 1: Lesson 1
End of participation and IP management
Master end-of-participation procedures including withdrawal versus discontinuation distinctions, follow-up requirements, and comprehensive investigational product accountability from receipt through final disposition.
End of participation and IP management
Not every trial ends with a final visit and a handshake. Participation ends in many ways, and not all of them are planned. A participant withdraws consent after three months. The investigator discontinues treatment because of toxicity. The sponsor closes the study early due to futility. In each scenario, obligations persist. Data must be preserved. Safety must be monitored. And every unit of investigational product must be accounted for.
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.
What you will learn
By the end of this lesson, you will be able to:
Good Clinical Practice (GCP)
Full course · ICH E6(R3) Principles