Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 7.1 - Investigator
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 5.2.1 |
| 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. [...]
