Table 7-1 Assessment Schedule Baseline Visit 2 Treatment Visit 32 Assessments Treatment Visits 4-10 Week 2-8 EOS Visit 114 Day 60 Day-14 Day 1 ka Screening Visit 12 Day -254 Xe X2 X2 le 1 X2 X2 Informed Consent Demographics Inclusion/Exclusion Medical History Physical Exam ECG Respiratory Virus Panel2 Urinalysis? Concomitant Medications Adverse Events Study Drug Administration33 X2 X2 X X X2 xe xe X2 X2 X xa 1 The 12-lead ECG will be performed in triplicate. Abnormal findings on the screening ECGs should be carefully considered and any subject excluded who in the judgment of the Investigator may not safely complete the study. 2 Assessments will be performed by the local laboratory. 3 Each study site will be supplied with study drug by the Sponsor. The study drug packaging has a 2-part label. Immediately before dispensing the package to the subject, investigator staff will detach the outer part of the label from the packaging and affix it to the source document for that subject's unique number. Investigator will observe each subject for 3 hours after each study treatment administration for the appearance of any acute drug reactions." Sample Pharma would like the University of Utah to participate in the PROTOCOL111-007 clinical trial. The attached protocol was forwarded to our site. Our immediate purpose is to calculate the cost of completing each visit and the entire trial (one participant).' In addition to the Assessment Schedule in the protocol, here is a list of additional assumptions." 1. Each participant will complete all procedures listed in the Assessment Schedule. - 2. Principal Investigator (PI) will contribute 1 hour per visit to trial oversight. This is in addition to what is included on the Assessment Schedule. 3. Study coordinator will spend on average 3 hours per visit with the exception of Visit 1 (5 hours) and Visit 3 (4 hours). This is in addition to what is included on the Assessment Schedule. 4. Here are the estimated times for the procedures: a. Informed Consent = 1 hr (Pl time) b. Demographics = 1 hr (Coordinator time) c. Inclusion/Exclusion Criteria = 1 hr (Coordinator time) d. Medical History = 2 hrs (Coordinator time) e. Concomitant Medications = 0.5 hr (Pl time) f. Adverse Events = 0.5 hr (Pl time) g. Study Drug Administration = 0.5 hr (Coordinator time) 5. Overhead rate is 36.5% of the total cost and is included in the cost of each visit. 6. The table below shows the list of CPT codes for procedures listed in the Assessment Schedule: Assessments Physical Exam Electrocardiogram RVP by PCR Urinalysis Serum CPT Code 992054 930002 876334 810014 ku 7. The tables below shows costs for various units: Rates $175 $54 k k $604 Assessments and Events Pl Time (per hr) Coordinator Time (per hr) Study Drug Administration (per dispensing) CPT Code 81001 CPT Code 876334 CPT Code 930004 CPT Code 99205 $374 $143 $235 $2954 Table 7-1 Assessment Schedule Baseline Visit 2 Treatment Visit 32 Assessments Treatment Visits 4-10 Week 2-8 EOS Visit 114 Day 60 Day-14 Day 1 ka Screening Visit 12 Day -254 Xe X2 X2 le 1 X2 X2 Informed Consent Demographics Inclusion/Exclusion Medical History Physical Exam ECG Respiratory Virus Panel2 Urinalysis? Concomitant Medications Adverse Events Study Drug Administration33 X2 X2 X X X2 xe xe X2 X2 X xa 1 The 12-lead ECG will be performed in triplicate. Abnormal findings on the screening ECGs should be carefully considered and any subject excluded who in the judgment of the Investigator may not safely complete the study. 2 Assessments will be performed by the local laboratory. 3 Each study site will be supplied with study drug by the Sponsor. The study drug packaging has a 2-part label. Immediately before dispensing the package to the subject, investigator staff will detach the outer part of the label from the packaging and affix it to the source document for that subject's unique number. Investigator will observe each subject for 3 hours after each study treatment administration for the appearance of any acute drug reactions." Sample Pharma would like the University of Utah to participate in the PROTOCOL111-007 clinical trial. The attached protocol was forwarded to our site. Our immediate purpose is to calculate the cost of completing each visit and the entire trial (one participant).' In addition to the Assessment Schedule in the protocol, here is a list of additional assumptions." 1. Each participant will complete all procedures listed in the Assessment Schedule. - 2. Principal Investigator (PI) will contribute 1 hour per visit to trial oversight. This is in addition to what is included on the Assessment Schedule. 3. Study coordinator will spend on average 3 hours per visit with the exception of Visit 1 (5 hours) and Visit 3 (4 hours). This is in addition to what is included on the Assessment Schedule. 4. Here are the estimated times for the procedures: a. Informed Consent = 1 hr (Pl time) b. Demographics = 1 hr (Coordinator time) c. Inclusion/Exclusion Criteria = 1 hr (Coordinator time) d. Medical History = 2 hrs (Coordinator time) e. Concomitant Medications = 0.5 hr (Pl time) f. Adverse Events = 0.5 hr (Pl time) g. Study Drug Administration = 0.5 hr (Coordinator time) 5. Overhead rate is 36.5% of the total cost and is included in the cost of each visit. 6. The table below shows the list of CPT codes for procedures listed in the Assessment Schedule: Assessments Physical Exam Electrocardiogram RVP by PCR Urinalysis Serum CPT Code 992054 930002 876334 810014 ku 7. The tables below shows costs for various units: Rates $175 $54 k k $604 Assessments and Events Pl Time (per hr) Coordinator Time (per hr) Study Drug Administration (per dispensing) CPT Code 81001 CPT Code 876334 CPT Code 930004 CPT Code 99205 $374 $143 $235 $2954