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SR No. Visit Result Findings Comments
SR No. Visit Result Findings Comments
1. 2.
Visit
SCR1 SCR2
Result
Pass Fail
Findings
VSS is according to Appendix. Terminology for dosing not same on Visit Summary Screen. Action details 4 column is missing for Post PFT. Action Type value entered is wrong for Inclusion. Eosinophilic Inclusion is being displayed on VSS. Terminology for dosing not same on Visit Summary Screen. Action Type value entered is wrong for Randomization. Washout Not Met comment not available.
Comments
3.
WK0
Fail
4.
EWV
Fail
Wrong Entry of Comment in Column Action details 4 for Washout Check. Terminology for dosing not same on Visit Summary Screen. Date is being displayed in column Action details 1 for Sputum Induction PFT, FEV is written in place
5.
SPUT
Fail Terminology for dosing not same on Visit Summary Screen. Date is being displayed in column Action details 1 for Sputum Induction PFT, FEV is written in place of FEV1 in column Action details 3.
Pass Fail
3. WK0 Pass 4. EWV Pass 5. SPUT Pass Reschedule 1. SCR1 Pass 2. SCR2 Pass 3. WK0 Pass 4. EWV Pass 5. SPUT Pass Optional PFT and Optional FeNO Availability 1. SCR1 Pass 2. SCR2 Pass 3. WK0 Pass 4. EWV Fail
According to PRS. Sputum PFT not available According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. According to PRS. Optional PFT available before Washout Check According to PRS.
5.
SPUT
Pass