Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 3.2 - Responsibility
From GxPlex
| Document information | |
|---|---|
| Reference | WHO WHO - Guidelines for GCP for trials on
pharmaceutical products* 1995 |
| Validity area | WHO |
| Scope(s) | HM |
| Document name | WHO - Guidelines for GCP for trials on
pharmaceutical products* |
| Version / Revision | 1995 |
| Status | Current |
| Document type | International guideline |
| Language(s) | EN |
| Description | World Health Organization
WHO Technical Report Series, No. 850, 1995, Annex 3 Guidelines for good clinical practice (GCP) for trials on pharmaceutical products* |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 4 â Unit 4.4.0 |
| Scope | HM |
| Document part | 3.2 - Responsibility |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, Amendment, Serious adverse event, Ethics, Protocol |
Content
3.2 Ethics committee [...] The ethics committee has an ongoing responsibility for the ethical conduct of research, and therefore must be informed of all subsequent amendments to the protocol and of any serious adverse events occurring during the trial, or other new information likely to affect the safety of the subjects or the conduct of the trial. The ethics committee should be asked for its opinion if a re-evaluation of the ethical aspects of the trial appears to be required, or if there is any doubt regarding the importance of a protocol change or new information. [...]
