Investigator's brochure

Investigator’s Brochure (IB) – is a comprehensive document provided to clinical trial investigators containing detailed information about the investigational product being studied. It includes data on the product’s characteristics, including pharmacology, toxicology and pharmacokinetics, as well as product’s formulation, manufacturing and handling together with information on previous human experience.

Definitions

ICH E6(R2)

1.36 Investigator's Brochure:

A compilation of the clinical and nonclinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects .

See also

Another relevant pages

• IMP

Links to this page

• Investigator's Brochure (redirect page) ‎ (← links)
  • Essential documents ‎ (← links)
  • Protocol ‎ (← links)
• IB (redirect page) ‎ (← links)
  • Unexpected adverse drug reaction ‎ (← links)
• Investigator’s Brochure (redirect page) ‎ (← links)