1. Coordinator Webinar and Round Table Discussion
September 25, 2019

2. Coordinator Call Announcements and Reminders
Next Coordinator Call November 13th, 2019
Today’s Roundtable Hosts: To join Coordinator Webinars: Please enter as a guest, then add your first and last name or address. For Audio: Dial-In Number: (877) Passcode
TBD
Upcoming StrokeNet Meetings:
The in-person StrokeNet meeting will be Oct. 29th, Atlanta Georgia.

3. Project Updates CREST-2
Study Project Manager: Kassondra Guzman, BS
Study Investigators: Tom Brott, MD
James Meschia, MD
Data Managers: University of Alabama

4. CREST H CREST H PI’S: Randolph Marshall, MD Ron Lazar, PhD
David Liebeskind, MD
E. Sander Connolly, MD
Project Managers: Jaya Vijayan, CCRC – Mayo Clinic
Kevin Slane – Columbia University

5. Project Updates ARCADIA
Study Project Managers: Rebeca Aragon Garcia, BS
Pam Plummer, MSN, RN, CCRC
Study Investigators: Mitch Elkind, MD
Hooman Kamel, MD
Data Managers: Faria Khattak, MPH
Patty Hutto
Site Managing Monitor: Aaron Perlmutter

6. ARCADIA-CSI ARCADIA-CSI PI’s: Maarten Lansberg, MD, PhD
Ron Lazar, PhD
George Howard, PhD
Kevin Sheth, MD
David Tirschwell, MD
Max Wintermark, MD
Project Managers: Stephanie Kemp
Tashia Harris, MS
Data Managers: Christy Cassarly, PhD
Faria Khattak, MPH

7. Sleep SMART Sleep SMART PI’s: Devin Brown, MD, MS
Ronald Chervin MD, MS
Project Managers: Kayla Novitski, MPH, CCRP
Joelle Sickler, MSN, RN, CCRC, CCRA
Data Managers: Faria Khattak, MPH
Jocelyn Anderson, MPH
FusionHealth Clinical Operations Director: Helgi Helgason, MS
FusionHealth Contracts Help: Diane Sparks, RN, BS Wren Hanson, MBA
Regulatory Specialists: Jennifer Golan, MS
Emily Stinson, MS

8. MOST Project Updates Study Investigators: Opeolu Adeoye, MD, MS
Andrew Barreto, MD, MS
Jim Grotta, MD
Joe Brodericke, MD
Colin Derdeyn, MD
Prime Project Manager: Iris Deeds, BS, CCRP
NCC Project Manager: Dana R. Acklin Winfrey, BA
Data Managers: Holly Pierce, MS
Jocelyn Anderson, MPH
Monitoring Manager: Srikala Appana, MPH

9. Project Updates TRANSPORT2
Study Project Managers: Kristina Balderson, MHA, CCRC
Jamey Frasure, PhD, RN
Study Investigators: Wayne Feng, MD
Gottfried Schlaug, MD
Data Manager: Patty Hutto

10. Fralin Biomedical Research Institute, Virginia Tech, Roanoke, VA
Perinatal Arterial Stroke: A Multi-site RCT of Intensive Infant Rehabilitation (I-ACQUIRE)
Investigators:
Sharon Landesman Ramey, Ph.D. (Lead PI), Fralin Biomedical Research Institute, Virginia Tech, Roanoke, VA
Warren Lo, M.D. (Co-PI), Nationwide Children’s Hospital & The Ohio State University, Columbus, OH
Fralin Biomedical Research Institute, Virginia Tech, Roanoke, VA
Laura Bateman, Study Coordinator
National Coordinating Center
Kim Bernstein – Project Manager
Data Manager
Sara Butler

11. Project Updates ASPIRE
Project Managers: Catherine Viscoli, PhD Laura Benken, MBA, BS, CCRP Study Investigators: Kevin Sheth, MD Hooman Kamel, MD Data Managers: Teldon Alford Site Monitoring Manager: Aaron Perlmutter

12. FAQ: Reimbursement for the Participant Pregnant Partner ICF
The amount and method of payment a site reimburses for participant transportation is up to the site
Pregnant Partner ICF
Approved PP ICF is housed at the NCC. If you need it, we can send
MOP and other study specific documents
WebDCU Toolbox
Per patient Budget
Click on SOW Payment Schedule

13. Project Updates SATURN
Study Project Managers: Kimberlee Bernstein, BS, CCRP
Study Investigator: Magdy Selim, MD, PhD
Data Managers: Kavita Patel, BS, RN
Site Monitoring Manager: Aaron Perlmutter

14. NINDS Scott Janis, PhD Claudia Moy, PhD Joanna Vivalda, RN
NCC/NINDS Updates
The National Coordinating Center
Joe Broderick, MPI Pooja Khatri, MPI
Jamey Frasure, Director Rose Beckmann, Administration
Emily Stinson, Regulatory Jennifer Golan, Regulatory
Diane Sparks, Contracts Wren Hanson, Contracts
Jeanne Sester. Ed Coord Keri Davidson Pinger, Business Mgr.
NINDS Scott Janis, PhD Claudia Moy, PhD Joanna Vivalda, RN

15. Data Management Center Updates
WebDCU™/NDMC Team:
Yuko Palesch, MS, PhD, Co-PI
Wenle Zhao, PhD, Co-PI
Catherine Dillon, MS, CCRP, Associate Director of Trial Operations
Jessica Griffin, MHA, CCRP, Trial Operations Manager
Logan Sirline, MPH, Project Manager

16. 2018 Site Clinical Profile Annual Survey
The Site Clinical Profile Annual Survey for 2018 is now ready for data entry in WebDCU! Please start working on completing this survey for each of the sites under your RCC.
Reminders:
Data entered on these surveys are used for feasibility and site selection purposes.
Data entered on these surveys should be for the calendar year.
2016 survey is still available for viewing in WebDCU in case you need to refer back to what was entered for a site that year.

17. CIRB Updates CIRB Team Members: Michael Linke, PhD, CIP, CIRB Chair
Sue Roll, RN, BSN, CIRB Liaison
Keeley Hendrix, CIRB Coordinator
Jo Ann Behrle, CIRB HPA

18. Roundtable Discussion
Today’s Topic: Regulatory Updates Presenters: Emily Stinson,, MS – University of Cincinnati Jennifer Golan, MS – University of Cincinnati

19. General Information and Reminders
Site Survey past due August 1st.
Presenters for upcoming Meetings/Coordinators Calls.
StrokeNet National Meeting in-person meeting Oct 29th, 2019.
StrokeNet Meet and Greet Night before National Meeting Oct 28th.
No manager breakout session scheduled.

20. COI and DOA Process Change
As of September 1, the cIRB is only reviewing PI COI forms and any positive disclosures
Previously: all COI forms were needed for cIRB initial submission
Now: only PI COI forms will be needed for cIRB initial submission
COI forms still need to be completed for each study team member and filed at your site.
Reporting requirements for positive financial disclosures:
Notify you local IRB and follow their requirements for the disclosure
Send NCC the positive COI form and local IRB management plan for cIRB notification
WebDCU
COI’s for study team will no longer require uploading to WebDCU
COI forms will now be located under site documents, and only PI and positive disclosures are uploaded
Any positive COI’s will be uploaded as one pdf with the PI COI form
Continuing Review instructions
We will be collecting a COI form from the PI, and highly encourage checking with the rest of your study team for any changes in conflict of interest. Reporting will be done annually on the CR form.

21. Delegation of Authority Process Change
As of September 1, cIRB is no longer reviewing sites’ Delegation of Authority log
Previously all changes to the DoA needed to be reviewed and approved by the cIRB
DoA changes will now be reviewed and approved by the NCC Project Manager
All people documents will need to be uploaded and approved in WebDCU before study member can perform study procedures
COI form will need to be signed and kept on site
If removing site personnel make sure all people documents are current
PI Changes
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 managers and/or NCC regulatory specialists for further instructions

22. Informed Consent Amendment Process
For studies with protocol amendments that include informed consent changes
Project manager will distribute the PRIME study templates (tracked and clean) that contain the amendment changes
We are asking sites to locate their most recently approved Word version of the consent ( C- 030 Site name STUDY ICD v2.0)
Track changes on site specific word version consent form and send tracked and clean versions for cIRB submission
When saving the document, please update the version in the file name and specify tracked or clean
Friendly reminder to change the version in the footer of the consent.

23. Helpful Tips Communication
subject line (Trial name, Site name, subject)
Please do not combine studies into one
Please do not combine sites into one
Feel free to follow up
After site activation communicate with Project Manager for all modifications.
DoA changes
PI Changes
Adding locations or language to an approved ICD

24. Helpful Tips WebDCU
Initial will be sent to Primary Coordinator (PSC) with login instructions from WebDCU
PSC can then add additional study team members for access
Regulatory documents review – documents will be reviewed at the time of your readiness call
DoA is no longer needed for cIRB submission
Please still submit DoA asap and upload documents so release to enroll won’t be affected
COI forms will be located under site documents, and only PI and positive disclosures are uploaded
Waive Documents that are not applicable
Administrative amendment approvals, HIPPA, CA Bill of Rights, translations, recruitment materials etc.
Remember to look in WebDCU toolbox for study templates

25. Helpful Tips Consent Forms
Site name and associated locations
Primary Research location and any other location where study activities will be taking place need to be listed on the Local Site Context Form and the ICD(s)
Please reference the General ICD instructions
Managing Tracked Changes
Use the Word tracking feature. Do not highlight text
Always use the most recent word version of your site specific ICD
Creating a clean consent for CIRB submission
Correct any minor spacing issues
Correct font color and size