GCP Essential Documents: Investigators Brochure & Study Protocol
This Module is aimed at personnel in regulated industries who require an overview of two key documents used in a clinical trial – the Investigator’s Brochure and the Study Protocol. The purpose of each document is described along with recommended sections for inclusion according to ICH E6 guidelines.
Duration: 30 Mins
Description
Learning Objectives:
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Module Features:
Animations |
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Keywords
Clinical Trial Essential Documents ICH E6 IEC/IRB |
Investigator’s Brochure Protocol Amendment Regulatory Authority Study Protocol |
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