GCP Essential Documents: Investigator's Brochure & Study Protocol

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.

  • Category: Clinical Trials GCP - Intermediate

Description

After taking this e-Lesson, you will be able to:

  • Explain why documentation is essential in clinical studies
  • Explain the purpose of an Investigator's Brochure in a clinical trial
  • List the ICH recommended sections of an Investigator's Brochure
  • Explain the purpose of a Study Protocol in a clinical trial
  • List the ICH recommended sections of a Study Protocol
  • Explain why clarity and conciseness are important in a Study Protocol
  • Define 'Protocol Amendment' and why it might be necessary

KEYWORDS: Clinical Trial, Essential Documents, ICH E6, IEC/IRB, Investigator's Brochure, Protocol Amendment, Regulatory Authority, Study Protocol