Reference:ICH ICH E6 Guideline R3 (2025) Appendix B 6-002
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E6 Guideline R3 (2025) |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E6 Guideline |
| Version / Revision | R3 (2025) |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | GUIDELINE FOR GOOD CLINICAL PRACTICE |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 â Unit 5.4.1 |
| Scope | G |
| Document part | Appendix B
6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Protocol, Trial participant, Stopping rules, Investigator responsibilities, Investigational drug (IMP) |
Content
B.6 Discontinuation of Trial Intervention and Participant Withdrawal from Trial The investigator may choose to discontinue the participant from the trial. Conversely, the participant may decide to withdraw from the trial or stop treatment with the investigational product (see sections 2.8.10(l), 2.8.10(m) and 2.9.1). The protocol should specify: (a) When and how to discontinue participants from the trial/investigational product treatment; (b) The type and timing of the data to be collected for withdrawn/discontinued participants, including the process by which the data are handled, in accordance with applicable regulatory requirements; (c) Whether and how participants are to be replaced; (d) The follow-up for participants who have discontinued the use of the investigational product.
