How many parts are there in the ICH E6 guideline?

How many parts are there in the ICH E6 guideline?

• A. Five
• B. Six
• C. Eight
• D. Ten

Answer: (C)

The ICH E6 guideline, known as "Good Clinical Practice" (GCP), is divided into eight parts. This structure reflects the comprehensive nature of the guideline, which addresses various critical aspects of conducting clinical trials. Each part encompasses different components of the standards and expectations for clinical research, including principles, responsibilities of various stakeholders, and essential documentation. The guideline ensures that clinical trials are conducted ethically, that the rights of participants are protected, and that data is credible and reliable. Therefore, recognizing that the guideline comprises eight distinct parts is crucial for understanding the regulatory framework governing clinical trials.

The ICH E6 guideline, known as "Good Clinical Practice" (GCP), is divided into eight parts. This structure reflects the comprehensive nature of the guideline, which addresses various critical aspects of conducting clinical trials. Each part encompasses different components of the standards and expectations for clinical research, including principles, responsibilities of various stakeholders, and essential documentation. The guideline ensures that clinical trials are conducted ethically, that the rights of participants are protected, and that data is credible and reliable. Therefore, recognizing that the guideline comprises eight distinct parts is crucial for understanding the regulatory framework governing clinical trials.