Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard: Difference between revisions
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{{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}} | {{:Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995}} | ||
{| class="gplx-infobox" | |||
{| class=" | |||
|- | |- | ||
! | ! colspan="2" class="gplx-infobox-header" | Reference Details | ||
|- | |||
! Scope | |||
| HM | | HM | ||
|- | |- | ||
! | ! Document part | ||
| 4.4 - immediate hazard | | 4.4 - immediate hazard | ||
|- | |- | ||
! | ! Language | ||
| EN | | EN | ||
|- | |- | ||
! | ! Original entry by | ||
| Florian Adragna | | Florian Adragna | ||
|- | |- | ||
! | ! Contributors | ||
| | | | ||
|- | |- | ||
! | ! Tags (EN) | ||
| | | | ||
|- | |- | ||
! | ! Tags (original language) | ||
| | | | ||
|- | |- | ||
! | ! Tags (FR) | ||
| | | | ||
|- | |- | ||
! | ! Comment | ||
| Investigator changes to study require sponsor agreement | | 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 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. | 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. | ||
Revision as of 14:27, 29 June 2026
| 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 | |
|---|---|
| Scope | HM |
| Document part | 4.4 - immediate hazard |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| 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.
