Study Schedule. The schedule of procedures and assessments during the study is summarised in Table 4 for Screening and Treatment 1 follow-up and in Table 5 for retreatment assessment and follow-up. Table 4 Study Procedures and Assessments for First Treatment and Follow-Up Until Retreatment or End of Study Screening Treatment Post-Treatment 1 Follow-up End of Study/ Withdrawal Screening Visit 1 Screening Visit 2 [i] [r] Treatment Visit (Day 1) [i] Week 1 Visit (Day 8) Week 2 Visit (Day 15) Week 4 Visit (Day 29) Week 6 Visit (Day 43) Week 12 Visit (Day 85) Routine Visit every 12 weeks (84 days) until retreatment occurs End of Study Visit (Week 104 to Week 116) [q] Clinic Clinic Clinic Telepho ne [n] Clinic Telepho ne [n] Clinic Clinic Telephone [n] Clinic Visit window (days) -30 to -1 [r] Within 14 days of Screening Visit 2 [i] ±3 days ±3 days ±3 days ±3 days ±7 days ±14 days ±14 days Informed consent X Demographic data X Medical/surgical/NDO history X Prior medications and therapies X Inclusion/exclusion criteria X X X Concomitant medications and therapies X X X X X X X X X X Prior and concomitant treatments for NDO [a] X X X X X X X X X X Adverse events X X X X X X X X X X Physical examination (symptom-based) X X X Xxxxx xxxxx X [f] X [m] X X X X Urinary tract ultrasound X [g] Urine pregnancy test [b] X X Laboratory urinalysis/microscopy [c] X X X X Urine culture [c] X X [o] CCI ] Haematology and serum chemistry X X X Anti BTX-A antibodies X X X Dispense bladder diary & training [d] X Bladder diary review X [k] X[k] X[k] X [k] X [k] X [k] I-QoL and EQ-5D-5L X X X X mPGI-I [e] X X X X X Urodynamics (filling cystometry) X [l] X [o] Randomisation X IMP administration X BTX-A=botulinum toxin type A; EOS=End of Study; EQ-5D-5L=EuroQol 5-dimension 5-level; IMP=investigational medicinal product; I-QoL=incontinence quality of life; mPGI-I=modified patient global impression - improvement; NDO=neurogenic detrusor overactivity. a Concomitant treatments for NDO (e.g. anticholinergics, beta-3 agonists, clean intermittent catheterisation rate) should remain stable during the first 12 weeks after Treatment 1 (preferably for the entire duration of the study). b Pregnancy test to be performed only in females of childbearing potential. Must be performed prior to randomisation on the day of treatment. c Laboratory urinalysis/microscopy and urine culture to be performed at any follow-up visit if there is a suspicion of urinary tract infection based on subject symptoms. x Xxxxxxx diary device...
Study Schedule. (A) Study Completion Date The Parties’ estimated completion date for the Study is set forth in Clause K(1) of the Mandatory Contract Clauses.
Study Schedule. (1) Study Completion Date The Contract Parties’ estimated completion date for the Study is [date].
Study Schedule. Initial Year: 1988 Final year: Ongoing
Study Schedule. The required study schedule for study participants is shown in Section 14.0 and Appendix 12.
Study Schedule. (A) Study Completion Date The completion date for the Study, which is , is the date by which the parties estimate that the Study will have been completed.
Study Schedule. Before accepting a co‐op position, students are responsible for discussing with their academic advisor how co‐op work tours affect their academic plan. Students who will participate in a full‐time co‐op for two or more semesters, or whose satisfactory academic progress may be affected by participation in a full time co‐op, are required to provide proof to Engineering Career Services that they have reviewed their four year plan with their academic advisor. Students in QUEST or other special campus programs should consult with their program administrators before accepting a co‐op position that may conflict with program requirements. Graduate assistants should consult with their supervisors before accepting a co‐op assignment that might conflict with their obligations to the University of Maryland. Acceptance oc Co‐op Employment The student is obligated to the first internship/co‐op offer s/he accepts. XXxx accepting a position, the student should discontinue their search for the same term.
Study Schedule. During the semester, students on F-1 visas are permitted to work a maximum of 20 hours per week, including campus work/assistantships and CPT-eligible internships. There is no limit during summer, winter or spring breaks. Only part- time CPT can be authorized in a student’s final term. Graduate assistants should consult with their supervisors before accepting any co-op assignment that might conflict with their obligations to the University of Maryland.
Study Schedule. A proposal for an ISP shall be submitted by a doctoral student and his/her supervisor no later than one month after the commencement of studies. All doctoral students shall have an approved ISP within three months of the commencement of studies.
Study Schedule. Projected Open to Accrual Date: Projected Enrollment Period: Projected Total Study Accrual:
