CITI Training Practice Exam

Does ICH or FDA require the investigator to inform the subject's primary physician about the subject's participation, given consent?

1. FDA

2. ICH

3. Both FDA and ICH

4. Neither FDA nor ICH

The correct answer is: ICH

The ICH (International Council for Harmonisation) and FDA (Food and Drug Administration) both have regulations and guidelines in place for clinical trials to ensure the safety and well-being of participants. However, when it comes to informed consent and informing the subject's primary physician, it is primarily the responsibility of the investigator. Both FDA and ICH expect the investigator to disclose any known risks and potential effects of the study to the subject's primary physician, in order to ensure their continued health and well-being. Therefore, options A and C are incorrect as they suggest that only the FDA or both the FDA and ICH are responsible for informing the subject's primary physician. Option D is also incorrect as both regulatory bodies expect the investigator to inform the subject's primary physician.