What is involved in a Clinical Trial?
You will meet the study coordinator and your 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, all required study procedures, exams and tests.
You will be given the Informed Consent Form explaining the study in detail. If you decide to participate you will be asked to sign the consent form. Your consent to participate is strictly voluntary and you have the right to withdraw at any time.
The Screening Process
You will be interviewed regarding your medical history and all current medications.
Screening exams, tests, procedures and physical exams will be done according to the requirements of each particular study. These procedures were discussed in the initial interview and on the Informed Consent form.
After all of the screening tests and procedures results are complete and you are eligible to continue according to the study guidelines, you will then start the study procedures Some patients may not qualify for the study. Those individuals will stop all study procedures when deemed ineligible.
After completing the screening process, you will be assigned the study medication. Each study will have its own 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, if any, at each study visit. Depending on the study, you may be required to have additional testing and procedures throughout the study.