Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.8
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 1 â Unit 1.5.4 |
| Scope | G |
| Document part | III. Annex 1
3.8 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor, Ethics committee, Competent authority, Sponsor safety reporting, Regulatory submission |
| Comment | Sponsor communication with IRB/IEC and regulatory authority |
Content
3. SPONSOR [...] 3.8 Communication with IRB/IEC and Regulatory Authority(ies) 3.8.1 Notification/Submission to Regulatory Authority(ies) In accordance with applicable regulatory requirement(s), before initiating the clinical trial(s), the sponsor (or the sponsor and the investigator) should submit any required application(s) to the appropriate regulatory authority(ies) for review, acceptance and/or permission to begin the trial(s). Any notification/submission should be dated and contain sufficient information to identify the protocol.
3.8.2 Confirmation of Review by IRB/IEC (a) Where reference is made to a submission to the IRB/IEC, this can be made by the investigator/institution or sponsor in accordance with applicable regulatory requirements (see section 1.1). (b)The sponsor should ensure that the following is obtained:
(i) The name and address of the relevant IRB/IEC along with:
(aa) A statement that it is organised and operates according to GCP and the applicable regulatory requirements;
(bb) Documented initial and subsequent IRB/IEC approval/favourable opinion as well as any termination of the trial or the suspension of approval/favourable opinion.
