Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.3
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 | |
|---|---|
| Scope | G |
| Document part | III. Annex 1
2.3 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Investigator delegation of trial-related activities |
Content
2.3 Responsibilities 2.3.1 The investigator may delegate trial-related activities to other persons or parties. The investigator may be supported by the sponsor in the identification of a suitable service provider(s); however, the investigator retains the final decision on whether the service provider intended to support the investigator is appropriate based on information provided by the sponsor (see section 3.6.5). The investigator retains the ultimate responsibility and should maintain appropriate oversight of the persons or parties undertaking the activities delegated to ensure the rights, safety and well-being of the trial participants and the reliability of data. The level of investigator oversight of the delegated activities should depend on the nature of the delegated activities and be proportionate to the importance of the data being collected and the risks to trial participant safety and data reliability.
2.3.2 The investigator should ensure that persons or parties to whom the investigator has delegated trial-related activities are appropriately qualified and are adequately informed about relevant aspects of the protocol, the investigational product(s) and their assigned trial activities (including activities conducted by staff provided by other parties in accordance with local regulatory requirements). Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience.
2.3.3The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated trial-related activities. Documentation of delegation should be proportionate to the significance of the trial-related activities. In situations where the activities are performed as part of clinical practice, delegation documentation may not be required.
2.3.4 Agreements made by the investigator/institution with service providers for trial-related activities should be documented.
2.3.5 The investigator/institution should permit monitoring and auditing by the sponsor, inspection by the appropriate regulatory authority(ies) and, in accordance with applicable regulatory requirements, review by IRB/IEC(s).
