Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.5
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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
2.5 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Investigator obligation to comply with and sign protocol |
Text
2.5 Compliance with Protocol 2.5.1The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the sponsor.
2.5.2The investigator should comply with the protocol, GCP and applicable regulatory requirements.
2.5.3The investigator should document all protocol deviations. In addition to those identified by the investigator themselves, protocol deviations relevant to their trial participants and their conduct of the trial may be communicated to them by the sponsor (see section 3.11.4.5.1(b)). In either case, the investigator should review the deviations, and for those deviations deemed important, the investigator should explain the deviation and implement appropriate measures to prevent a recurrence, where applicable (see section 3.9.3).
2.5.4The investigator should follow the protocol and deviate only where necessary to eliminate an immediate hazard(s) to trial participants. In case of deviations undertaken to eliminate immediate hazard to trial participants, the investigator should inform the sponsor promptly.
2.5.5The investigator should report information on the immediate hazard, the implemented change and the subsequent proposed protocol amendment, if any, to the IRB/IEC and, where applicable, regulatory authorities (see section 1.1).
