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