Question

According to ICH E6, who should explain the correct use of the investigational product(s) to each study subject and check, throughout the study, to see if each subject is following the instructions properly?

a) Principal investigator
b) Sub-investigator
c) Study coordinator
d) Pharmacist

Answer 1

According to ICH E6, the principal investigator should explain the correct use of the investigational product(s) to study subjects and ensure compliance.

Step-by-step explanation:

According to ICH E6, the correct answer is a) Principal investigator. The principal investigator is responsible for explaining the correct use of the investigational product(s) to each study subject and checking, throughout the study, to see if each subject is following the instructions properly. The principal investigator plays a crucial role in ensuring the safety and compliance of study subjects.