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Avanir 20-AVP-786-306/307

Checklist for Baseline Visits

Prior to any subject visit, please make sure the tablet has been synced

Baseline Visit Checklist


 Baseline Visit Form (Pages 1-17)
o Complete the living and caregiver section in order to roll out the correct NPI form
 Complete scales (First 5, must be in this order)
o CMAI
o NPI-AA/NPI-AA-NH
o CGIS-Agitation
o MMSE
o S-STS (must be signed by PI)
o EQ-5D-5L (ensure tablet is held in portrait mode and the stylus pen is used for the scale
to function properly)
o RUD-Lite
o ESS (only for patients with an MMSE score of ≥10 at Baseline)
 Complete all other procedures including pre-dose ECG

 Register the visit by clicking the “pill” icon


• Successful (Subject has passed the blinded criteria) -> Complete the
following:
o Finish the Baseline Visit Form
▪ Ensure status is updated from “Screened” to
“Randomized”
▪ Confirm IP dispensation in the tablet
• Unsuccessful (Subject has failed baseline blinded criteria) -> Complete
the following:
o Finish the Baseline Visit form
▪ Ensure status is updated from “Screened” to “Screen
Failed”

For Any tablet issues, please call Clinical Ink support at 1-800-301-5033 and request that the Support
technician stay on the call until the visit is complete for any further issues that may arise if the site can
manage this.

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