Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.6
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 6 â Unit 6.1.2 |
| Scope | G |
| Document part | III. Annex 1
2.6 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Early termination, Temporary halt, Investigator responsibilities, Trial participant |
| Comment | Investigator obligations on premature termination or suspension |
Content
2. INVESTIGATOR [...] 2.6 Premature Termination or Suspension of a Trial 2.6.1 If the trial is prematurely terminated or suspended for any reason, the investigator/institution should promptly inform the trial participants and should ensure appropriate therapy and follow-up for the participants.
2.6.2Where the investigator terminates or suspends their involvement in a trial without prior agreement by the sponsor, the investigator should promptly inform the institution, where applicable, the sponsor, the IRB/IEC and the regulatory authorities in accordance with applicable regulatory requirements and should provide a detailed explanation of the reasons.
2.6.3 If the sponsor terminates or suspends a trial, the investigator/institution or the sponsor, in accordance with applicable regulatory requirement(s), should promptly inform the IRB/IEC and the regulatory authorities and should provide an appropriate explanation (see section 3.17.1).
2.6.4 If the IRB/IEC terminates or suspends its approval/favourable opinion of a trial (see sections 1.2.3 and 1.4.9), the investigator should inform the institution, where applicable, and the investigator/institution should promptly notify the sponsor.
