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What To Expect in a Clinical Trial

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 – All clinical studies are different, so the exact procedures performed at a screening visit may vary. However, the informed consent process will take place at every screening visit. Once you have signed informed consent 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. This visit usually lasts about 60 to 90 minutes.

 

Confirmation Phone Call – Once all of the results from the screening tests are in and the doctor has reviewed your results and your information, he/she will 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.

 

Baseline Visit – This is your first official study visit. Usually at this visit you are dispensed the study drug and given directions on dosage, documentation of dosing and other instructions. You may also have labs drawn or other procedures. During this visit you and the study coordinator will also set up your visit schedule so you understand when you need to come into the office for study visits. This visit usually lasts between 60 to 90 minutes.

 

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. 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. These visits usually last between 30 to 60 minutes.

 

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 visit will be performed. In order to continue your care, the coordinator will usually schedule a regular office visit with your physician for you in the next few months according to your usual treatment schedule. This visit usually lasts 60 to 90 minutes.

 

Between Visits – Your coordinator and physician are always available to take your calls or see you between study visits. If you have questions or are experiencing side effects, you can be seen in the office usually within one business day.
 

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