ICH E6 – Clinical Trial Protocol and Protocol Amendments (Chapter 6) (R2)

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects.

The objective is to provide a unified standard for the EU, Japan, and US to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

This course explores the standard clinical protocol and related documents we use to comply with GCP.

By the end of this course, you should be able to:

• Identify clinical trial protocol requirements.
• Define protocol compliance.
• Provide examples of optional and related protocol documents.
• Describe the clinical trial protocol structure.
• Discuss the expected information to be included in each individual protocol section.