Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.14-001
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| 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 2 — Unit 2.3.4 |
| Scope | G |
| Document part | III. Annex 1
3.14 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Insurance, Participant compensation, Sponsor, Written agreement, Investigator |
Content
3.14 Insurance/Indemnification/Compensation to Participants and Investigators 3.14.1 If required by the applicable regulatory requirement(s), the sponsor should provide insurance or should indemnify (legal and financial coverage) the investigator/the institution against claims arising from the trial except for claims that arise from malpractice and/or negligence.
3.14.2 The sponsor’s policies and procedures should address the costs of treatment of trial participants in the event of trial-related injuries in accordance with the applicable regulatory requirement(s).
3.14.3 The approach to compensating trial participants should comply with applicable regulatory requirement(s).
