Coordinator Webinar and Round Table Discussion JULY 24, 2019

Coordinator Call Announcements and Reminders Next Coordinator Call August 28th, 2019 Today’s Roundtable Hosts: To join Coordinator Webinars: https://nihstrokenet.adobeconnect.com/coordinator/ Please enter as a guest, then add your first and last name or email address. For Audio: Dial-In Number: (877) 621-0220 Passcode 434578. RCC presentations Upcoming StrokeNet Meetings: The in-person StrokeNet meeting will be Oct. 29th, 2019. Atlanta Georgia.

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

Project Updates ARCADIA Study Project Managers: Rebeca Aragón Garcia, BS Pam Plummer, MSN, RN, CCRC Study Investigators: Mitch Elkind, MD Hooman Kamel, MD Data Managers: Faria Khattak, MPH Jocelyn Anderson, MPH Patty Hutto

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

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

Project Updates TRANSPORT2 Study Project Managers: Kelly Krajeck, BS Jamey Frasure, PhD, RN Study Investigators: Wayne Feng, MD Gottfried Schlaug, MD Data Managers: Patty Hutto

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 laurapb2@vt.edu National Coordinating Center Teresa Murrell-Bohn, RN, CCRC, ACRP-PM – Project Manager murreltm@ucmail.uc.edu Data Manager Sara Butler

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

Project Updates SATURN Study Project Managers: Kimberlee Bernstein, BS, CCRP Study Investigator: Magdy Selim, MD, PhD Data Managers: Kavita Patel, BS, RN

The National Coordinating Center NCC/NINDS Updates The National Coordinating Center Joe Broderick, MPI Pooja Khatri, MPI Jamey Frasure, Director Teresa Murrell-Bohn, Sr. Project Manager Jeanne Sester, Ed Coord Rose Beckmann, Administration Emily Stinson, Regulatory Jen Golan, Regulatory Diane Sparks, Contracts Wren Hanson, Contracts Keri Pinger, Finances Karen Rolf, Finances StrokeNet Central Pharmacy The NINDS Scott Janis, PhD Joanna Vivalda, RN

MTAs RCCs will continue to have MTAs Satellites will no longer have MTAs StrokeNet CIRB Reliance Agreements will be required to be fully executed to be trial eligible. ************************************************************************************ INFORMATION NEEDED FOR ANNUAL REPORT OR CHANGE RCC (WebDCU# and name) RCC PI RCC Coordinator RCC Clinical Performing Sites (WebDCU# and name) (If new just state “NEW”) RCC Satellites (WebDCU# and name) (If new just state “NEW”) RCC Satellite PI RCC Satellite Coordinator RCC Satellite Clinical Performing Sites (WebDCU# and name) (If new just state “NEW”)

PROCESS Send an email to Diane Sparks, NCC Contracts Manager, Legal Liaison diane.sparks@ucmail.uc.edu Annually - and for any changes RCC or Satellite PI or Coordinator change. Don’t forget to update WebDCU for these changes. Satellite or CPS Bought out Mergers & Acquisitions Satellite or CPS name changes (frequently happens with large donation that includes donor naming rights) Additional Clinical Performing Sites New Satellites (check with the NCC (Diane Sparks) prior to telling the Satellite they are part of StrokeNet (she will need the DUNS# of the entity that does the contracting for federally sponsored research and the FWA number or numbers). Once she has cleared them, you can congratulate them. The NCC (Diane Sparks) will communicate with the NDMC (Jessica Griffin) regarding the changes. (Allow a month to 6 weeks for changes to be reflected in WebDCU. Their first priority is getting the new trials programed.) If a trial is adding “Out-of-Network” sites, the NCC (Diane Sparks) will communicate with WebDCU regarding those “Out-of-Network” sites and which trial(s) they will be participating in. (Allow a month to 6 weeks for changes to be reflected in WebDCU. Their first priority is getting the new trials programed.) If an “Out-of-Network” site becomes a Satellite of a RCC, the NCC (Diane Sparks) will communicate with the WebDCU regarding that change. (Allow a month to 6 weeks for changes to be reflected in WebDCU. Their first priority is getting the new trials programed.)

Data Management Center Updates WebDCU™/NDMC Team: Yuko Palesch, MS, PhD, MPI Wenle Zhao, PhD, MPI Catherine Dillon, MS, Operations Manager Jessica Griffin, BS, CCRP, Project Manager

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 2018 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.

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

Roundtable Discussion Today’s Roundtable Discussion: Improving the CIRB Submission Process Hosts: Nichole Gallatti, M.S.Ed, CCRP Stroke Clinical Trials Project Coordinator The Greater Philadelphia NIH StrokeNet (GPNSN) University of Pennsylvania Jason Weimer Program Coordinator NIH StrokeNet Regional Coordinating Center University of Pittsburgh

General Information and Reminders Site Survey 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. Future calls to allow sites to present their RCC’s. Topics or presenters for the Atlanta Meeting.