Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 4.4 - immediate hazard: Difference between revisions
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| | |has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | ||
| | |module=5 | ||
| | |unit=5.4.1 | ||
| | |scope=HM | ||
| | |doc_part=4.4 - immediate hazard | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00246-Inv-hte ++ TAG-00017-Spo-die ++ TAG-00069-Imm-rhe ++ TAG-00041-Ame-run ++ TAG-00329-Saf-lne | |||
|tags_display=[[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00017-Spo-die|Sponsor]], [[Glossary:TAG-00069-Imm-rhe|Urgent safety measure]], [[Glossary:TAG-00041-Ame-run|Amendment]], [[Glossary:TAG-00329-Saf-lne|Safety]] | |||
|comment=Investigator changes to study require sponsor agreement | |||
|content=[...] | |||
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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. | ||
}} | |||
Latest revision as of 13:50, 16 July 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 | |
|---|---|
| Module | Module 5 — 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 |
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.
