Certified Clinical Research Associate (CCRA) Practice Exam 2025 – All-in-One Guide to Master Your Certification!

Informed consent in clinical research is an ethical requirement that ensures potential participants are fully aware of the study's nature before agreeing to participate. While there are specific elements that must be included in informed consent, such as the purpose of the research, the procedures involved, risks, benefits, and the right to withdraw, the inclusion of the number of subjects involved in the study is not a universally mandated element.

However, including the number of subjects can help provide context regarding the study’s design and the collective experience of participants; knowing the scope may reassure potential subjects about the research's credibility and the representation of their personal data. This helps foster transparency and trust in the research process.

It is essential, though, to note that informed consent primarily focuses on the individual participant’s rights and safety, rather than the overall composition of the study group. Therefore, the best response is that it is not a definitive requirement for all studies and may vary based on specific regulatory and ethical guidelines, making 'true' not universally applicable.