Research Study Discussion of Clinical Trial - The first thing that happens when you are contemplating participating in a clinical study is that the doctor or study staff will call you and discuss the study details with you. If you are still interested in participating you will be scheduled for a screening appointment.
Screening Appointment – After agreeing upon the details and procedures explained to you in the research study discussion, an informed consent process will take place at every screening visit. All clinical studies are different, so the exact procedures performed at a screening visit may vary. Once you have signed the informed consent document and agreed to participate in the study, the study coordinator will complete screening procedures such as obtaining a blood and urine sample, vital signs, a complete medical history and a medication check. Please allow 1 to 2 hours for this visit. (*)
Confirmation Phone Call – Once all of the results from the screening tests are in and the doctor has reviewed your results along with the information you provided to us regarding your medical history, the doctor will then make a decision regarding your qualification to participate. The study coordinator will call you and inform you of this decision. If you do qualify, you will be scheduled for your baseline visit. If you DO NOT qualify, we thank you for your time and interest, and no other visits are required.
Baseline Visit – This is your first official study visit. At this visit, you are usually dispensed the study drug and given directions on dosage, documentation of dosing and other instructions. You may also have labs drawn or other procedures performed. During this visit, you and the study coordinator will also set up your visit schedule so you understand when you need to come back into the office for further study visits. (*)
Study Visits – All studies vary in length. Some studies may only last a few weeks, others may last a few years. The length of your study determines the number of study visits you will have. Here is what you can begin to expect in the early stages of a study in regards to the amount of visits you will be expected to make:
Typically in the beginning of a study the visits are usually more frequent – sometimes as often as every two weeks.
As the study progresses you can be seen less often – usually every three or six months.
At each of these visits you will need to bring your study medication and any diaries you were dispensed. The study coordinator will count your medication and dispense more medication to you. The coordinator could also take a blood and/or urine sample and obtain vital signs, an electrocardiogram or other procedure. (*)
End of Study – At your last study visit all medication will be collected and you will not receive any more medication from the study. Procedures that are very similar to the one you did at the screening appointment will be performed. In order to continue your care, the coordinator will usually schedule a regular office visit for you with your physician in the next few months according to your usual treatment schedule.
Between Visits – Your coordinator and physician are always available to take your calls or see you between study visits. Please feel free to reach out to either resource if you have questions or are experiencing any side effects. In most cases, you can be seen in the office within one business day.
(*) Every study is different and the actual length of the visit can vary considerably. Your study coordinator and/or doctor will give you more information at your screening visit in regards to the approximate length of each visit.
To view our current list of studies, click here.
If you would like to become a volunteer, click here.