Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator: Difference between revisions
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| | | [[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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Revision as of 17:29, 15 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 |
| Comment | Recording and reporting adverse events at site level |
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. [...]
