Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure: Difference between revisions
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{{ | {{ReferenceData | ||
| | |has_document=Document:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 | ||
| | |module=2 | ||
| | |unit=2.1.4 | ||
| | |scope=HM | ||
| | |doc_part=Glossary - investigator’s brochure | ||
| | |language=EN | ||
| | |entry_by=Florian Adragna | ||
|contributors= | |||
|tags=TAG-00034-Inv-Bro ++ TAG-00244-Def-ini | |||
|tags_display=[[Glossary:TAG-00034-Inv-Bro|Investigator's brochure]], [[Glossary:TAG-00244-Def-ini|Definition]] | |||
|comment=Definition of investigator's brochure (GCP) | |||
|content=investigator’s brochure | |||
A collection of data for the investigator consisting of all the relevant information on the investigational product(s), including chemical and pharmaceutical data and toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and the results of earlier clinical trials. There should be adequate data to justify the nature, scale and duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new data are generated, the investigator’s brochure must be updated. | |||
}} | }} | ||
Latest revision as of 13:49, 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 2 — Unit 2.1.4 |
| Scope | HM |
| Document part | Glossary - investigator’s brochure |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator's brochure, Definition |
Content
investigator’s brochure A collection of data for the investigator consisting of all the relevant information on the investigational product(s), including chemical and pharmaceutical data and toxicological, pharmacokinetic and pharmacodynamic data obtained from studies in animals as well as in humans, and the results of earlier clinical trials. There should be adequate data to justify the nature, scale and duration of the proposed trial and to evaluate the potential safety and need for special precautions. If new data are generated, the investigator’s brochure must be updated.
