Certified Clinical Research Associate (CCRA) Practice Exam

Who is allowed direct access to subjects' medical records in a clinical study?

1. Only the subject

2. Only the investigator

3. Subject and Investigator

4. Research staff only

The correct answer is: Subject and Investigator

In a clinical study, both the subject and the investigator are permitted direct access to the subjects' medical records. This access is crucial for the investigator to assess the safety and efficacy of the intervention being tested, as well as to ensure that the subjects meet the eligibility criteria for the study. The investigator must monitor participants' health and any adverse events that occur throughout the study, which requires access to relevant medical information. The subject retains the right to access their own medical records, which empowers them to understand their health status and take an active role in their care. This transparency is essential for informed consent, where the subject must be fully aware of what participation entails. While research staff may have access to certain information necessary for conducting the study, that access is often limited and not direct in the same sense as the subject and the investigator. Privacy regulations, like HIPAA in the United States, dictate that any access to personal health information should be managed carefully and ethically, but the roles of both the subject and investigator are critical and typically unrestricted concerning necessary medical records for the study.