End of Study Visit Sample Clauses

End of Study Visit. You will be asked to complete a second Quality of Life survey and your records will be reviewed. You will be required to relinquish both the activity monitor and the video monitoring system at this visit. Your dog will be humanely treated at all times and all investigative procedures will be performed using the customary methods applied to all other client-owned patients at NC State University Veterinary Hospital. POSSIBLE DISCOMFORTS AND RISKS There are no known risks and side effects associated with use of a collar mounted activity monitor.
Sample 1
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End of Study Visit. (7 ± 2 days after last study visit or decision to terminate) For all patients:  Collect and review completed diary.  Perform physical examination (see Section 9.10).  Measure height and weight.  Calculate BMI and BSA (see Appendix 14.5).  Measure xxxxx xxxxx (blood pressure, heart rate, respiratory rate, and oral body temperature, see Section 9.11).  Obtain clinical laboratory tests (serum chemistry, hematology, and urinalysis, see Section 9.7).  Obtain a 12-lead ECG (see Section 9.9).   Administer the VAS measurement of swallowing difficulty (see Section 9.13).  Record concomitant medications.  Monitor AEs. For patients still receiving RP103 treatment:  Subjects should be fasting for at least 2 hours prior to RP103 dosing.  A meal or snack will be ingested between 30 and 60 minutes after RP103 dosing.  Administer Q12H RP103 dose with an acceptable food or liquid as described in Appendix 14.9.  Collect a cysteamine PK sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded.  Collect a WBC cystine PD sample 0.5 hour (30 minutes) post RP103 dose administration. Actual collection time will be recorded. For patients that terminated from the Study and transitioned onto Cystagon® treatment:  Collect a cysteamine PK sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded.  Collect a WBC cystine PD sample immediately prior to their next Cystagon® dose administration. Actual collection time will be recorded. If a subject has any clinically significant, Study drug-related abnormalities at the conclusion of the study termination, the Investigator will determine if the subject has to be followed further. If the Investigator determines that a subject has abnormalities that require additional monitoring, the subject may be asked to return to the clinic until the abnormalities resolve or will be allowed to return home and will be followed up by telephone until resolution. If the subject is to be followed up, the Medical Monitor (or designated representative) should be notified. Every effort should be made to arrange follow-up evaluations at appropriate intervals to document the course of the abnormalities.
Sample 1
End of Study Visit. Week #6 At Week 6, the last clinic visit, the following information will be collected and tests will be performed: • Your blood alcohol level will be measured using a breathalyzer. If your blood alcohol is greater than 0.020, you may not be able to complete your visit as scheduled. If your blood alcohol level is very slightly higher than 0.020, study staff may give you the option of waiting until it reaches 0.000 to continue with your visit. If you blood alcohol level is 0.080 or higher and you drove to your visit, study staff will ask you to remain in the clinic until you are capable of leaving without risking your (or others) safety. • A urine sample to test for drug use. • A blood sample to check your liver, kidney, thyroid gland, and immune system functions • Questions about thoughts or attempts of harming yourself, and alcohol withdrawal symptoms. • Xxxxx xxxxx and weight measured. • Questions about any medications you are taking (or have taken since the last visit). • An ECG will be performed. • Questions about your cravings for alcohol and alcohol withdrawal symptoms. • Fill out questionnaires or answer questions about your mood, desire to quit drinking, sleep, drinking urges, smoking cigarettes, and use of other nicotine products. • Your daily alcohol use since your last visit. • Questions about your experience with the study drug. You will also be provided with information about your options for continued treatment of your alcohol use disorder. You will be required to bring your used and unused bottles with you every time you attend a clinic visit. For your own safety and to ensure our study results are valid, we ask that you provide truthful and honest information when answering any of the study related questions. Not telling study staff about parts of your previous medical history, medications you are taking, or symptoms you are having, could put your health at risk and ruin the study findings. Please provide staff with complete and honest answers throughout the study. If you experience a side effect, you may have unscheduled visit(s) to make sure you are well at the discretion of the investigator.
Sample 1
End of Study Visit. The EOS Visit will take place between 104 and 116 weeks after the first IMP administration (Day 1). Subjects may receive study retreatment up to and including Week 104 and a minimum of 12 weeks of follow-up is required after each IMP administration. For those subjects completing the study, the EOS Visit will occur: • 104 weeks after the first IMP administration; if it has been more than 12 weeks since the previous IMP administration • At the Week 12 Retreatment Follow-up Visit, if the subject received their most recent IMP administration between Week 92 and Week 104 following their first IMP administration. Early discontinuation A subject who discontinues early should, if at all possible, be followed-up for at least 12 weeks following their most recent IMP administration and should attend the EOS Visit. Number of subjects planned: 330 randomised subjects. Diagnosis and criteria for inclusion: Inclusion criteria The following inclusion criteria will be assessed at the beginning of the Screening process: 1) Written informed consent prior to any study-related procedure. 2) Male or female, aged 18 to 80 years inclusive. 3) UI for at least 3 months prior to Screening as a result of NDO due to SCI or MS. 4) Subjects with SCI must have a stable neurological injury at T1 level or below which occurred at least 6 months prior to Screening. OR Subjects with MS must be clinically stable iu the iuvestigator's opiuiou, with no exacerbation (relapse) of MS for at least 3 months prior to Screening. 5) Subjects in the non-urodynamic subset only, must have NDO (defined as the presence of involuntary detrusor contractions during the storage phase of urodynamic filling cystometry) on a historic urodynamic assessment performed in the 12 months prior to Screening • If urodynamics are not performed in the 12 months prior to Screening or if results are not available, then a urodynamic filling cystometry assessment must be performed during Screening, per local practice (see inclusion criterion # 16).
Sample 1
End of Study Visit. The EOS Visit will take place between 104 and 116 weeks after the first IMP administration (Day 1). Subjects may receive study retreatment up to and including Week 104 and a minimum of 12 weeks of follow-up is required after each IMP administration. For those subjects completing the study, the EOS Visit will occur: • 104 weeks after the first IMP administration; if it has been more than 12 weeks since the previous IMP administration • At the Week 12 Retreatment Follow-up Visit, if the subject received their most recent IMP administration between Week 92 and Week 104 following their first IMP administration. CCI
Sample 1
End of Study Visit or Early Withdrawal Visit 63 6 TREATMENT OF SUBJECTS 65 6.1 Investigational Medicinal Product Administered 65
Sample 1
End of Study Visit or Early Withdrawal Visit 63 6 TREATMENT OF SUBJECTS 65
Sample 1
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Related to End of Study Visit

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