Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard
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 5 â Unit 5.4.1 |
| Scope | HM |
| Document part | 4.4 - immediate hazard |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, Sponsor, Urgent safety measure, Amendment, Safety |
| Comment | Investigator changes to study require sponsor agreement |
Content
[...] The investigator should not make any changes in the study without the agreement of the sponsor, except when necessary to eliminate an apparent immediate hazard or danger to a trial subject. [...] The investigator may take any steps judged necessary to protect the safety of the trial subject, whether specified in the protocol or not. Any such steps must be documented.
