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Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator: Difference between revisions

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|tags_display=[[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00062-Med-tre|Medical care]], [[Glossary:TAG-00343-Doc-ten|Documentation]]
 
|comment=Recording and reporting adverse events at site level
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|content=7.1 Handling of and recording adverse events
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! colspan="2" class="gplx-infobox-header" | Reference Details
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| Module 5 — Unit 5.2.1
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| HM
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! Document part
| 7.1 - Investigator
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! Language
| EN
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! Original entry by
| Florian Adragna
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! Tags
| [[Glossary:TAG-00045-Adv-hte|Adverse event]], [[Glossary:TAG-00246-Inv-hte|Investigator responsibilities]], [[Glossary:TAG-00062-Med-tre|Medical care]], [[Glossary:TAG-00343-Doc-ten|Documentation]]
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| Recording and reporting adverse events at site level
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== Content ==
7.1 Handling of and recording adverse events
In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of the trial subjects. This includes providing the best possible care for subjects experiencing any trial-related adverse events and conducting a thorough investigation to determine causality.
In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of the trial subjects. This includes providing the best possible care for subjects experiencing any trial-related adverse events and conducting a thorough investigation to determine causality.
[...]
[...]
}}

Revision as of 12:56, 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 5.2.1
Scope HM
Document part 7.1 - Investigator
Language EN
Original entry by Florian Adragna
Contributors
Tags Adverse event, Investigator responsibilities, Medical care, Documentation

Content

7.1 Handling of and recording adverse events In accordance with Sections 4.1 and 4.3 of these guidelines, the investigator must ensure the safety of the trial subjects. This includes providing the best possible care for subjects experiencing any trial-related adverse events and conducting a thorough investigation to determine causality. [...]

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