Lesson Code: CGI-1202. This Lesson 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.
After taking this e-Lesson, you will be able to:
KEYWORDS: Clinical Trial, Essential Documents, ICH E6, IEC/IRB, Investigator's Brochure, Protocol Amendment, Regulatory Authority, Study Protocol