During your first visit please be ready to stay here for approximately 2 hours. You will be given a consent form to read and have the opportunity to ask any questions. If you decide to proceed, paperwork will be started once the consent form is signed. Blood and urine samples will be collected, an EKG may be done and a physical exam will be conducted. Once you have completed the necessary evaluation you will be scheduled for additional study specific diagnostic testing.
Our facility follows HIPAA regulations. We will review your medical records that are provided to our facility from your physician’s office and share your information only to those individuals with a need to know basis. We will ask you to sign a medical release form if you wish for us to share your health information with anyone else.
You (and/or your health insurance company) will not be expected to pay for any of the study procedures, the study drug, or tests that are part of this research study. Procedures that are standard of care for your condition will be your responsibility. This could include any non-study procedures that are needed while you are in the study. It could also include any medications that are not a part of the study.
If fasting is required, please do not eat or drink after midnight, unless it is water. Your study team will be able to tell you if fasting is required. In addition, please do not take your immediate/short acting insulin on an empty stomach. Please make sure to drink plenty of water the day before and the day of your visit.
A clinical trial is a research study designed to evaluate potential new treatment options for patients. These trials provide medical knowledge related to the treatment, diagnosis, and prevention of diseases or conditions. Every clinical trial is led by a principal investigator, who is generally a medical doctor. Clinical trials also have a research team that may include doctors, nurses, study coordinators and other health care professionals.
Each trial has certain requirements about a participant’s medication, age, gender and current and past health history. In order to be an eligible participant of a particular trial, you must meet the requirements. Some research studies seek participants with specific illnesses or conditions to be studied in a clinical trial, while others require healthy participants. It is important to note that inclusion and exclusion criteria are used to identify appropriate participants, promote participants’ safety, and ensure that researchers learn the information they need.
Volunteers in a clinical trial participate in the development of medical therapies that may offer better treatments and even cures for life-threatening and chronic diseases. There are rigorous guidelines in place to protect the safety and well-being of the participant, however, there may be risks involved:
• Clinical research is the future of medicine. Patients who participate may have access to cutting edge drugs and/or therapies and can help to shape treatment for future patients.
• Visits and procedures related to the study may be free of charge. Those may include physical examinations, doctor visits, study medications, laboratory tests and other study related procedures. Health insurance is not required and you may be compensated for your time and travel.
• You may learn more about your condition or disease and the latest treatments available.