Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trial
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 1 â Unit 1.2.1 |
| Scope | HM |
| Document part | Glossary - clinical trial |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Clinical trial, Definition, Investigational drug (IMP) |
| Comment | Definition of clinical trial (systematic study on pharmaceutical products) |
Content
clinical trial A systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reaction to investigational products, and/or to study the absorption, distribution, metabolism and excretion of the products with the object of ascertaining their efficacy and safety. [...]
