Frequently Asked Questions
Our Investigators, Doctors, medical staff, and other health care professionals have many years of experience and work under strict rules and regulations set by the Food and Drug Administration (FDA). These rules protect clinical trial participants/volunteers and make sure they are treated as safely as possible. Research studies are also overseen by medical ethics groups to ensure that study participants are treated appropriately.
We care about our volunteers, and go to great lengths to protect your health/well-being, safety, and information throughout the studies.
es. You may leave the trial at any time. However, if you do decide to leave, you should let the study team know and tell them why you are leaving. Early termination procedures will be done to ensure your safe exit from the study.
What should I expect to happen during my first visit?
On your first visit you will be given an Informed Consent Form. An Informed Consent goes over the purpose of the study, the risks, benefits, known side effects, all procedures that will be required during the trial, and many other important aspects that you will need to know. It is an agreement by a patient to take part in the trial after they have been informed of and understand exactly what they will be taking part in. You may take a copy of the Informed Consent home with you to review, and make your decision. You will also be asked to sign a Release of information form which will allow us to request your medical records. This is to make sure you are eligible for a study, and to determine whether or not this treatment will be the right thing for you. All medical records are kept secure and are completely confidential.
Once the consent form has been explained, discussed and signed by all applicable parties (some studies require a caregiver or other such individual to be present during this process), and we receive your medical records, you will begin the procedures of the actual study or be scheduled to come in another day depending study requirements, and your availability.
Clinical trials are research studies on volunteers that are designed to answer specific questions about medical treatments like vaccines, medications, functional foods, dietary supplements, devices or even new ways of using known treatments. This is done to gather data on safety and efficacy of a certain treatment. They are conducted only after enough information has been gathered that satisfies health authority and ethics committee approval.
By conducting clinical trials on new types of treatment, we learn whether or not they are safe and effective. Conducting studies on currently approved treatments can help us find new indications. Research studies are needed to develop new treatments for many conditions, so that they can be approved by the FDA for doctors to prescribe.
All research studies have certain requirements which must be met for eligibility. These requirements vary with each study, and may include factors such as age, gender, type of medical condition, and current medication use.
People participating in clinical research studies have access to experimental treatments before they become available to the general public, free of cost. If you participate, you will receive careful medical attention during your examinations and tests. Also, you will be helping others in the future by contributing to medical research. In most cases, you may be reimbursed for your time and expenses, such as travel.