Study Procedures, Visit Descriptions and Adherence Sample Clauses

Study Procedures, Visit Descriptions and Adherence. To ensure consistency of the manualized therapy, each type of visit described below must follow the treatment manual. Adherence to the manualized therapy will be reviewed by monitoring of data and/or rating videos of these visits as part of the data review process. All criteria for a visit type should be completed as a part of the visit series, which may take place over more than one day. 5.2.1 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 investigator for the treatment period of the study. d. Collect perceptions of the third experimental session. e. The study physician will obtain medical and psychological history by interview. f. The study physician will collect information on pre-study and current medications. g. The study physician will perform a general physical examination. The examination will involve the following procedures: • Blood pressure • Pulse • Height • Weight • Body temperature • Examination of head, eyes, ears, nose, throat, skin, heart, lungs, abdomen and extremities • Brief neurological exam (cranial nerves 2-12, sensory, motor, reflexes and cerebellar function) • Electrocardiogram (ECG) • Serum electrolytes, metabolic profile, urinalysis and complete blood count • Thyroid stimulating hormone (TSH), free T3 and free T4 • Human Immunodeficiency Virus (HIV) serology • Urine-dip pregnancy test on females with childbearing potential • Urinary drug test • C-SSRS to assess suicide risk Results of HIV serology will be kept confidential, and appropriate referral for counseling may be necessary in accordance with state law. The clinical laboratory values will be used to establish eligibility and will be kept with the subject’s source record. The clinical laboratory values will not be captured in the CRF, but will be used to establish eligibility and will be kept with the subject’s source record. Clinically significant abnormal values will be captured as medical history. If, upon examination, there are questions raised about possible medical problems, the study physician will request a review of subject medical records and request additional tes...
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