Reference:ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.9
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
3.9 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | Sponsor consideration of establishing an IDMC |
Content
3.9 Sponsor Oversight [...] 3.9.7 The sponsor may consider establishing an IDMC to assess the progress of a clinical trial, including the safety data and the efficacy endpoints, at intervals and to recommend to the sponsor whether to continue, modify or stop a trial.
3.9.8 Where appropriate, sponsors may also establish an endpoint assessment/adjudication committee in certain trials to review endpoints reported by investigators to determine whether the endpoints meet protocol-specified criteria. To minimise bias, such committees should typically be blinded to the assigned treatments when performing their assessments, regardless of whether the trial itself is conducted in a blinded manner.
3.9.9 Committees established for purposes that could impact participant safety or the reliability of trial results should include members with relevant expertise and with managed conflicts of interest, have written operating procedures (e.g., charters) and document their decisions.
