A potential subject is interested in a new clinical trial and would like to learn...

The Informed Consent Form (ICF) contains comprehensive information about the potential risks and benefits of participation in a clinical trial. It is a legally required document that ensures that subjects make an informed decision before enrollment.

The answer is consistent with GCP guidelines which mandate that the ICF clearly outlines the risks and benefits of participation to protect participant rights.

"The ICF should include a clear explanation of potential risks and benefits to ensure informed decision-making by the participant."

Objectives:

Ensure informed decision-making by potential subjects.

Provide transparent risk-benefit information.