Certified Clinical Research Associate (CCRA) Practice Exam

What is required from subjects regarding unused investigational drugs?

1. They can keep them for future use

2. They must return them to the site

3. They can donate them to charity

4. They can dispose of them as they see fit

The correct answer is: They must return them to the site

The correct response is that subjects must return unused investigational drugs to the study site. This requirement is part of the regulatory framework governing clinical trials, which aims to ensure the safety and integrity of the investigational product. Returning unused drugs allows for proper accountability and inventory management, enabling researchers to track the usage of the medication and ensure that it is handled in accordance with compliance standards. Additionally, returning the drugs helps mitigate risks associated with improper use or disposal, which could lead to safety concerns or adverse events. Other options, such as keeping the drugs for future use, donating them to charity, or disposing of them independently, are not permissible because they can compromise participant safety and the reliability of the trial data. By returning the drugs, researchers can safeguard against these issues and maintain the ethical standards of clinical research.