Participant Withdrawal Section
ICH E6(R3) addresses the end of participation separately from ordinary retention planning: investigators should follow the protocol when a participant withdraws or is discontinued, respect the right to withdraw without undue influence, and handle trial data in accordance with applicable requirements.
A Participant Withdrawal section explains what happens when participation or trial treatment ends early, how rights are protected, and how already collected or subsequently permitted data are handled under the protocol and applicable requirements.
Key details
Important caveats
Scope Boundary
Do not turn withdrawal procedures into pressure to remain enrolled. Retention strategy, missing-data analysis, consent law, and jurisdiction-specific data rights remain separate concerns.
Further guidance
Content
Describe withdrawal/discontinuation pathways, participant communication, permitted follow-up or data handling, responsibilities, and how the protocol governs already collected information.
Purpose
Make the operational and rights-based consequences of early withdrawal clear before the situation occurs.
Sources and evidence
Sources are shown with the role they play in this guide. Historical or style-sensitive claims are kept within the evidence boundary described above.
- E6(R3) Good Clinical Practice Guidance for Industry — September 2025 (opens in a new tab)U.S. Food and Drug Administration · Current ICH E6(R3) GCP guidance on investigator oversight, training/delegation, participant withdrawal, investigational-product accountability, site close-out, essential records, and insurance/indemnification