Reference:WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigator’s brochure

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
Scope	HM
Document part	Glossary - investigator’s brochure
Language	EN
Original entry by	Florian Adragna
Contributors
Tags (EN)
Tags (original language)
Tags (FR)
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.