Detailed information regarding patient safety what happens during your screening visit for any study is outlined below.
This is provided to help patients understand how their health, safety, privacy, and well-being will be protected and ensured.
All participants are guaranteed the opportunity to review the consent form thoroughly, ask any questions, and discuss the information with the research staff and physicians.
After you feel satisfied that you understand the material and have had all your questions answered, you may choose wether or not to sign the consent and enroll in the study or decline participation.
All laboratory tests results, physical exam findings, and other information applicable to your screening visit will be provided to you at no cost- whether or not you choose to enroll
There is never any obligation to continue or complete a study if you are unhappy with the investigational medicine or otherwise no longer able to participate
If you choose to continue with enrollment, both you and a research staff member sign the informed consent form. This signed form indicates both parties agree that you have been informed of the risks, benefits, study procedures, and treatment alternatives associated with the clinical study. You will be provided a copy to take home with you.
You will be promptly notified of any changes in the information contained in the informed consent form you sign, and will be given the same opportunity to review, discuss, ensure understanding, and choose to continue with the study or not based on the new information.