Association of Clinical Research Professionals (ACRP) Certified Professional Practice Exam

Where should a research subject's responsibilities for study participation be outlined?

1. Investigator's manual

2. Informed Consent Form (ICF)

3. Eligibility screening checklist

4. Clinical trial agreement

The correct answer is: Informed Consent Form (ICF)

The responsibilities of a research subject for study participation should be clearly outlined in the Informed Consent Form (ICF). The ICF is a critical document that ensures potential participants are fully informed about the study, including what is expected of them, the procedures involved, and any risks associated with participation. It serves not only to inform participants but also to protect their rights by ensuring they understand their role in the research. By detailing the subject's responsibilities, the ICF helps ensure that participants know what they need to do to contribute effectively to the research, such as attending visits, following protocols, and reporting any side effects. This clarity is essential for ethical research and compliance with regulatory standards. The ICF is signed by the participant, indicating their understanding and agreement to these outlined responsibilities. While the investigator's manual may contain relevant information for researchers about the study design and protocols, it is not meant for subjects. The eligibility screening checklist is focused on determining if individuals qualify to participate in the research, and the clinical trial agreement is a legal document governing the relationship between sponsors and researchers, without detailing participant responsibilities. Therefore, the ICF is the appropriate document for outlining the responsibilities of research subjects.