Certified Clinical Research Associate (CCRA) Practice Exam 2025 – Complete Preparation Guide

Verbal consent prior to participation in a clinical research study is permitted for individuals who are illiterate. In cases where a potential participant cannot read or fully understand the written consent documents due to illiteracy, obtaining verbal consent ensures that they are informed about the study and can make an educated decision regarding their participation. It is crucial that the information provided is clear, comprehensible, and sufficient for the participant to understand the nature of the study, its risks, benefits, and their rights.

For individuals who are underage or have a guardian, written consent is generally required from a parent or legal guardian in accordance with regulations to protect the rights and welfare of those unable to provide informed consent themselves. Also, the funding source of the study (such as being funded by a non-profit organization) does not dictate the appropriateness of verbal consent versus written consent; the focus is primarily on ensuring informed consent that is suitable for the participant's circumstances.