Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.17.1
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Document Information
| 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
| Scope | G |
|---|---|
| Document part | III. Annex 1
3.17.1 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Sponsor obligations on premature termination or suspension |
Text
3. SPONSOR [...] 3.17.1Premature Termination or Suspension of a Trial If a trial is prematurely terminated or suspended, the sponsor should promptly inform the investigators/institutions and the regulatory authority(ies) of the termination or suspension and the reason(s) for the termination or suspension. The IRB/IEC should also be informed promptly and provided with the reason(s) for the termination or suspension by the sponsor or by the investigator/institution, in accordance with applicable regulatory requirement(s). Where appropriate, the sponsor should provide the investigator with information about potential subsequent therapy(ies) and follow-up for the participants.
