Reference:ICH ICH E9 Guideline 1998 Glossary - IDMC
From GxPlex
| Document information | |
|---|---|
| Reference | ICH ICH E9 Guideline 1998 |
| Validity area | ICH |
| Scope(s) | HM |
| Document name | ICH E9 Guideline |
| Version / Revision | 1998 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | STATISTICAL PRINCIPLES FOR CLINICAL TRIALS E9 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 5 â Unit 5.3.2 |
| Scope | HM |
| Document part | Glossary - IDMC |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Data monitoring committee, Definition, Safety, Sponsor |
| Comment | IDMC / DSMB: definition and function |
Content
Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) An independent data-monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.
