A clinical research study is conducted according to a research plan known as a study protocol which is designed to answer specific research questions and to assure the safety of the participants. The protocol includes the following information:

• The reason for conducting the study
• Who may participate in the study (inclusion/exclusion criteria)
• The number of participants needed
• The schedule of tests, procedures, investigational product and their dosages
• The length of the study
• What information will be collected about the participants.

The following process generally occurs during the conduct of a clinical research study:

Pre-Screening

The clinical research study site will review their existing patient databases or medical charts to identify potential patients who may be eligible to participate in the clinical research study. They may also place advertisements on the internet, newspaper, radio, or television to recruit interested participants. They may also conduct seminars, free health screenings, or forums.

Potential participants from these pre-screening efforts are contacted and briefly interviewed to confirm if they are potentially eligible and willing to participate in the clinical research study.

Participant Information and Consent Form (ICF)

If you are potentially eligible to participate in a clinical research study, an appointment will be scheduled for you to come to the clinical research site and meet with one of the research staff members. Before any study related procedures are performed you will be required to sign an ICF which details the study design, risks and benefits, your rights as a study participant and who to contact in case of an emergency. During the informed consent process, you will have an opportunity to ask questions you may have regarding the study and your participation. You should receive a copy of the signed ICF for your records and future reference.

Screening Visit

Once you agree to participate in the clinical research study and have signed the ICF, the study screening procedures will be administered. The purpose of the screening visit is to determine if you meet the specific inclusion and exclusion criteria for the specific clinical research study you agreed to participate in. Generally, during the screening visit you may be asked to answer questions regarding your medical history, medications and other treatments you are taking, and complete questionnaires. A member of the research team may also assess your general health by performing a physical examination, ECG and collect blood/urine samples.

Generally, the investigational product is not dispensed during the screening visit.

Study Visits (Treatment Visits)

If you meet the specific inclusion and exclusion criteria (which includes study acceptable laboratory and medical results) for the study you will be asked to return to the clinic for a series of study visits sometimes referred to as Study Treatment Visits. Some of these study visits may be conducted virtually. It is generally during these study visits that a study participant will receive the investigational product or the comparator product (which sometimes can be a placebo). The number of study visits and the interval in which the visits occur varies from study to study.

End of Study Visit

Once you have reached the end of the study treatment visit, an End of Study Visit is conducted. Generally, the same or similar assessments conducted prior to you receiving the investigational product are repeated. The research team will also discuss your follow-up treatment options (which may include receiving standard of care treatments for your illness or continuing into an open label study of the investigational product) and if required by the study you may be asked to return to the research site for a follow-up safety visit.

Follow-up Safety Visit

The number of follow-up safety visits and the interval in which the visits occur varies from study to study. The purpose of this visit is to assure you are not experiencing any lingering side-effects from the investigational product or from the overall participation in the study.

Risks are involved in clinical research, as in routine medical care and activities of daily living. Most clinical research studies pose side effects that are temporary and go away when the study treatment is stopped. However, some research subjects experience side effects that can be permanent or require medical attention. Some side effects appear during study treatment, while others may not show up until after the study treatment is over.

Some investigational products that are being tested have side effects that can be unpleasant, serious or even life-threatening. Because the investigational products being studied are new, researchers don’t always know what the side effects will be in humans.

The specific risks associated with any research protocol are described in detail in the ICF document, which you are asked to sign before taking part in research. In addition, the major risks of participating in a study will be explained to you by a member of the research team, who will answer your questions about the study. Before deciding to participate, you should carefully weigh these risks. Although you may not receive any direct benefit as a result of participating in a clinical research study, the information collected by your participation may help others.

To help you decide if you want to be in a study, study participants are given complete information about the study before they agree to take part.

ICFs should be written so the participant can easily understand it and should include:

• purpose of the research
• how long the study will take
• what will happen in the study and which parts of the study are experimental
• possible risks or discomforts
• possible benefits
• other procedures or treatments that the participant might want to consider instead of the treatment being studied
• that FDA may look at study records, but the records will be kept secret
• whether any medical treatments are available if the participant is hurt, what those treatments are, where they can be found, and who will pay for the treatment
• the person to contact with questions about the study, participant rights, or if the participant can get hurt
• the participant can quit at any time

If you don’t understand the information included in the ICF, be sure to ask the doctor or other research staff member to explain it. This discussion should take place in private, and you must be given enough time to make an informed decision. In most studies, you should be allowed to take the consent form home for further discussion with others, such as family, caregivers and primary care physicians. Make sure you understand all of it before you agree to be in the study.

Before you can be in the study, you must sign the ICF, showing that you have been given this information and understand it. The ICF form is NOT a contract and you can leave the study at any time, for any reason. You may ask questions at any time throughout the study.
In addition, you must also be informed of any new information learned during the study that may affect your willingness to continue to participate in the study.

Here are some questions to ask your doctor to help you decide if you want to take part in a clinical trial:

• What is the study trying to find out?
• What kinds of test and exams will I have to take while I’m in the study? How much time do these take? What is involved in each test?
• How often does the study require me to go to the doctor or clinic?
• Will I be hospitalized? If so, how often and for how long?
• What are the costs to me? Will my health insurance pay for it?
• What follow-up will there be?
• What will happen at the end of the study?
• What are my other treatment choices? How do they compare with the investigational treatment being studied?
• What side effects can I expect from the investigational treatment being tested? How do they compare with side effects of standard treatment?
• How long will the study last?

The clinical research team will make every effort to assure that your Personal Health Information (PHI) is kept extremely confidential. Your information will not be shared without your permission or except and to the extent as may be required by applicable law.

If you choose to submit your information through this website, with your permission, this information will be entered into our clinical research database for both current and future study opportunities. You can ask to have your information removed at any time. If you choose to call in and speak to one of our research specialists over the phone, your information will be captured in the same electronic database. Again, this is voluntary and can be removed at any time.

In most clinical research studies all visits, tests, and procedures related to the study are at no cost. If you qualify for one of our research studies, you may be compensated for travel. The amount of compensation (as well as any expenses not covered by the study) will be reviewed during the ICF process.