You will meet the study coordinator and the physician who will be tracking your progress during the study. The research study will be explained to you in detail including the potential risks and benefits, alternatives to participation, length of the study, number of required study visits and all required study procedures, exams and tests.
If you volunteer to participate in a research study, you must sign an Informed Consent Form, which explains the study in detail and confirms that you understand all aspects of the trial. Your consent to participate is strictly voluntary and you have the right to withdraw your consent at any time.
The Screening Process
You will be interviewed regarding your medical history and all current medications.
Screening exams, tests, procedures, physical exams will be done according to the requirements of each particular study. These procedures were discussed in the initial interview and are included on the Informed Consent form.
After completing all of the required screening tests and procedures, you are eligible and will then start the study procedures. Some patients may not qualify for the study, and, if deemed ineligible, will stop all procedures.
After you complete the screening process and are accepted for participation, you will be assigned the study medication according to the individual schedule, which was discussed at the initial interview and on the Informed Consent form.
Your compliance with taking the study medication will be assessed throughout the study. You will be required to return all study medication containers at each study visit. Depending on the study, you may be required to keep a daily diary between visits, and there may be additional testing and procedures required throughout the study.
After the Study
At the end of the study, the study coordinator and the physician will conduct a final assessment, including a physical exam, and they will collect all remaining study supplies. They will also make follow-up recommendations, if appropriate. You may be contacted in the future for any new studies in which you may be interested.