1. PI and Coordinator Webinar September 18, 2019

2. Overview Site Status and Randomization WebDCU Reminders
FusionHealth Processes

4. Randomizations September randomizations:
Mayo Clinic Saint Mary’s, Rochester MN- Amy Headlee & Eugene L. Scharf MD
Saint Luke’s, Kansas City MO- Debbie Summers, Christine Kennish, & Suzanne Crandall MD
SUNY Upstate Medical, Syracuse NY- Lena Deb & Gene Latorre MD
Harborview Medical Center, Seattle WA- Allison Kunze & Sandeep Khot MD
Sarasota Memorial, Sarasota FL- Jeanette Wilson, Daniel Hernandez, & Mauricio Concha MD
UPMC Presbyterian, Pittsburgh PA- Patricia Feineigle, Jason Weimer, & Sherry Chou MD 
University of Utah, SLC UT- Theodore Rock & Jana Wold MD
Sites open to enrollment: 43
Subjects enrolled: 160
Subjects randomized: 45

5. Site Readiness FusionHealth Consignments Agreements: 81
FusionHealth Data Use Agreements: 87
Clinical Trial Agreements: 102
CIRB approved sites: 83
Sites with all contracts executed and CIRB approval: 69
In order to schedule your site readiness call, the following need to be completed:
Both FusionHealth Consignment and DUA executed
CTA executed
CIRB Approval
All required training completed and uploaded in WebDCU- Trainings can be found here
KOEO access confirmed and equipment received by site
Dummy Nox T3 test completed

6. New DOA Process
Starting 9/1, sites will no longer need CIRB approval for DOA changes (addition and removal of site personnel).
Sites will continue to make these changes in WebDCU as before.
The changes will go in effect once the DOA is approved by the project manager and all required training and other people documents have been uploaded and approved in WebDCU.
Consider having all required documents completed and ready to upload as soon as your DOA is approved.
If you are removing site personnel make sure all people documents are current. WebDCU is considered the site Trial Master File.
Request to make a PI change will need to be approved by the study team. Before making this DOA change please reach out to the project manager(s) and/or NCC regulatory specialist(s) for further instructions.

7. Misc
If your Nox T3 has been shipped to you, please complete a dummy T3 test before your readiness call. Reach out to Kayla/Helgi and we can provide you with instructions on how to do this.
For any FusionHealth contract communications, please include Kayla at on all s. Greg has been out, and we want to be sure your s are being answered.
If you are attending the November workshop in Atlanta, please do not forget to book your hotel room and flight before October 15th.

8. F506 aCPAP Run-In Night
Q01: ‘Conducted’ is defined as aCPAP device turned on and applied to subject, irrespective of the duration of aCPAP use
If the run-in night was conducted, Q01 must be answered as ‘Yes’ and all data need to be provided, so please remember to copy the below data from the device
Make comment about payment

9. 3 and 6 Month Assessments
When conducting the assessments at the 3 and 6 month visits, please refer to the following instructions:
The blinded study team member should administer all questionnaires. When feasible, the subject can visually follow along with the response options using the study team member’s copy of the questionnaire.

10. Data Entry Reminders
Please remember to enter screen failures into WebDCUTM
Screen failures are subjects who were approached for consent, but declined.
Please remember to report adverse events
CRF data must be submitted within 5 days of collection
Exceptions:
Adverse Events must be submitted within 5 days of knowledge of the event
Death must be reported within 24 hours of knowledge of the event
When a subject is found to be ineligible for randomization, please remember to move them to End of Study and complete the F126 End of Study CRF within 5 days

11. Who to Contact? Srikala Appana at NDMC appana@musc.edu
When to contact: If you have WebDCU-related DOA/regulatory database questions, Informed Consent Remote Monitoring questions, or Site Monitoring questions
Faria Khattak at NDMC
When to contact: Any other WebDCU-related or CRF-related questions
Jocelyn Anderson at NDMC
When to contact: Any other WebDCU-related or CRF-related questions

12. Sleep SMART Process Reminders September ‘19

13. Sleep SMART Naming Regimen

14. Reminder on how to Create New Patient
Enter the following fields then click Save on top right.
100160

15. Potential Next Tasks after Scoring

16. Excluded - Print Report Task

17. Excluded - Print Report
Reminder: Please complete the Excluded - Print Report Task in KOEO
This task appears if subject is NOT ELIGIBLE for Run-In Night.
Process must be closed out

18. Excluded - Print SleepSMART Report

19. Be Sure to Perform Dummy Tests

20. The Benefits of completing a Dummy Test
Gets you familiar with Process
We can Troubleshoot IT Security issues that may arise due to firewall / Proxy Settings
T3 is a USB device. Many IT Security issues have been addressed.
All BEFORE you consent a subject.

21. T3 and the Oximeter

22. Attaching the oximeter to the hand
If scoring team has less than 3 hours of viable oximetry data to work with, they will invalidate the study
Repeat T3 Setup Task
Subject needs to wear longer

23. Precautions

24. The T3 and Oximeter Together
DO NOT MIX AND MATCH OXIMETERS and T3s
The T3 and Nonin3150 oximeter that are together in the carry case are configured to ONLY connect to each other
The Serial Number of T3 and the Nonin3150 are paired in KOEO.
If you take other oximeter from the other carry case and put it on the subject, no oximetry data will be recorded via the bluetooth. Study will be invalidated.
If you have a malfunctioned oximeter or you are unsure which oximeter belongs with your T3s, let HGH know
extension 4006

25. Starting a Recording

26. KOEO vs the KOEO Interactive Tool

27. T3 Setup Task in KOEO

28. Login and Locate T3 Setup Task in KIT

29. T3 Setup Task in KIT

30. Upload T3 Data Task in KOEO

31. Login and Locate T3 Upload Task in KIT
Will automatically load correct subject data from plugged in T3.

32. KOEO vs KIT Reminders You MUST complete task in KOEO
Google Chrome - app.koeo.com
T3 Setup or Upload T3 Data
The KOEO platform is the SleepSMART process
The KOEO Interactive Tool (KIT) is just the conduit to configure or upload data
Think first about the Task
Think second about the Tool

33. Questions?
Reminder that our next webinar will be Monday, October 21st from 1-2 EST.