What Is a Clinical Research Study?
Clinical research studies, also called clinical trials, look at an investigational drug or medical device to see if it is safe, how it works in the body, and if it works to treat a specific disease. Clinical research studies are conducted by doctors who are responsible for the study participants’ study-related care.
In most countries, the regulatory health authority, such as the US Food and Drug Administration (FDA), requires that several phases of clinical research be performed to better understand the safety and effectiveness of new investigational drugs and certain medical devices.
Clinical research studies must be approved by an institutional review board (IRB) or ethics committee (EC). An IRB/EC is a group that is responsible for helping to protect the rights and well-being of study participants. In addition, every study participant is monitored with study-related medical tests and exams before, during, and sometimes even after the study.
Can I Leave a Clinical Study If I Change My Mind?
Participation in any clinical study is completely voluntary, and participants may choose to leave at any time for any reason. If you would like to leave a study, you should discuss this with your study doctor, who will give you information about how to do this safely.
What Should I Expect?
Before you can take part in the CNP-103 Clinical Trial, you will first need to attend the screening visit(s) for initial tests and assessments to see if you are eligible to participate. After all necessary tests and assessments have been completed, and if you are eligible to participate, you may enter the study and receive the assigned study treatment.
How Long Will Study Participation Last?
Participation in the CNP-103 Clinical Trial lasts approximately 13 months.
Is There a Cost to Participate?
There is no cost to participate. All study-related exams, medications, and medical care are provided. There is no insurance required to take part in this study. You may be compensated for time, travel, and expenses.
How Will My Data Be Used and Protected?
Protecting your privacy is one of COUR’s top priorities. All personal and medical information collected during a study is kept confidential and stored securely. Your data is anonymized (your name and identifying details are removed) and used only for approved research purposes in compliance with global privacy laws such as General Data Protection Regulation (GDPR) and Health Insurance Portability and Accountability Act (HIPAA).
We will store your information only for the duration of the CNP-103 Clinical Trial. After the study ends, your data will be securely deleted.