GCP Essential Documents: Investigator's Brochure & Study Protocol


Lesson Code: CGI-502. Describes the essential documentation associated with the clinical trials process with emphasis on the Investigator's Brochure and Study Protocol.


  • Category: Clinical Trials GCP - Intermediate

Description

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

- Explain what is meant by 'essential document' in a Clinical Trial

- Explain the purpose and contents of an Investigator's Brochure

- Explain the purpose of a Clinical Trial Protocol

- Describe what should be included in a Clinical Trial Protocol