Role Of Study Participant Your Role As A Study Participant   As a study participant, you are given the product being tested. Then, after a certain amount of time and at planned intervals, blood and other specimens are collected. These samples are analyzed to monitor the product’s performance in or on the body. We conduct these studies to show the manufacturer how long and how well the medication works.   Steps Of A Study Screening Your safety is our primary concern. Before being accepted for any study, you will be given an informed consent packet to read and review, as well as a time and events calendar. You will also complete a medical history packet. We recommend you bring important names or dates concerning your medical history (i.e. dates of surgeries, types of medications). Once you agree to the terms and conditions of the informed consent packet and complete the medical history packet, you will proceed to the labwork portion of the procedure. MDS staff will measure your height, weight, temperature, blood pressure, pulse, and collect urine and blood samples. The initial labwork process takes approximately 90 minutes.     Results You will call MDS Pharma Services Results Line for your labwork results. If you have difficulty calling during the time specified, arrange with a family member or a friend to call in for you. This is a competitive call. You will not receive your results by coming to the facility or by calling any other phone number. You must have your screening ID number in order to receive your labwork results. Once you are advised that you have passed your labwork, a physical examination appointment will be scheduled.   Doctor Exam Our physician will give you an exam and possibly an Electrocardiogram (ECG). The physician will also answer your study-related questions. Women should wear a two piece outfit for the exam. The physical exam process takes approximately 45 minutes.   Study Acceptance Upon completion of the physical exam, you will be informed if you are accepted for the study. You will be provided with a date and time for study check-in. You will also be given information and special instructions to follow prior to your check-in. Remember, placement onto a study is never guaranteed. It is ultimately up to the doctor and the client to decide who will be placed onto a study.   Expectations and Responsibilities           The following expectations and responsibilities are intended to protect your rights and the success of the study. If you need to cancel, we need to make arrangements for a replacement. Let us know immediately if you will be unable to complete the study. Failure to contact us could place you on an “Ineligibility” status. Time schedules are very important. It is imperative that you check-in and report for your scheduled events as instructed. Consumption of alcohol and medications, including vitamins and herbals, is strictly prohibited. MDS Pharma Services has scheduled strict sleeping times that must be observed. Uncooperative, disruptive, or abusive behavior is grounds for dismissal from the study. A study participant may be further sanctioned by being placed on a “Ineligibility” status. If you damage facility furniture or equipment, expenses will be deducted from your study payment and could effect future participation. If your study allows smoking, it is permitted in designated areas. You will not be permitted to leave the clinic during your stay with us. If an emergency arises or you choose to leave, you must contact the Study Manager. For health reasons, blankets and pillows are not permitted in the courtyard. For the health and safety of you and those around you, used gauze pads should be placed in a biohazard box. For your safety and for accurate testing results, you will have a specific diet during your stay at MDS Pharma Services. You must eat all the food provided and at the times specified. The menus planned for your study are available at the time of your physical examination. Food cannot be shared or saved and it must be eaten in the dining area. Sunbathing is not allowed during the study period.  Exercise may be limited during your study. You will be informed by your Study Manager what level of activity is permissible. Pay phones are provided for your use. Please bring your own change to make outgoing calls. If you expect to receive incoming calls, give the caller the number of the pay phone in your area. Cell Phones are permitted as long as they do not have a camera. If you experience any problems or have any concerns after you leave MDS Pharma Services, contact a nurse on the 24-hour nurse’s line.