Visit Descriptions Sample Clauses

Visit Descriptions. 9.4.1 Prescreening, Screening, and Baseline Evaluation (Pre-study) a. Explain and obtain written informed consent from the subject. Written informed consent must be obtained prior to performing any tests or evaluations for the study. b. Assign the subject a screening number. Complete the Screening Log. c. Review the ability of females of childbearing potential to become pregnant and their commitment to practice appropriate birth control as determined by the PI for the treatment period of the study. d. The PI will obtain medical and psychological history by interview. e. The PI will collect information on pre-study and current medications. f. Tinnitus and chronic pain symptom severity will be collected using a visual analog scale in subjects with a medical history of these conditions. g. A physician will perform a general physical examination. The examination will involve the following procedures: • Blood pressure. • Pulse. • Height. • Weight.