Coordinator Webinar and Round Table Discussion

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Presentation transcript:

Coordinator Webinar and Round Table Discussion March 28th, 2018

Coordinator Call Announcements and Reminders Next Coordinator Webinar : Next Coordinator Call April 25, 2018. Devin Qualls, Kinga Aitken and Henna Olalde. Today’s Roundtable Host is STEPHANIE WILBRAND, University of Wisconsin. 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. Upcoming StrokeNet Meetings: Plan Ahead: Montreal World Stroke Conference, October 16th, 2018. NCC will reimburse for one night stay at $250.

Network Meeting at WSOC, Montreal 16-October 2018 StrokeNet will reimburse two people from each RCC ONE night room and tax, up to $250. Meeting venue is the Palais des Congrès, downtown Montreal, not a hotel; book your hotel via the Congrès link to receive Congrès rates: https://hotel.kenes.com/en/congress/WSC18; this link, and a link to the WSOC can also be found in the BWU. Meeting will tentatively run 9:00 am to 2:00 pm. There will be no formal breakout sessions, however, the Coordinator/Managers can meet informally after the meeting if desired , as we have the room until 4:00 pm. RSVP information will be sent out soon. Passports can take six weeks to process. Please apply as early as possible. StrokeNet cannot reimburse for costs associated with passports. https://travel.state.gov/content/travel/en/passports/apply-renew-passport/how-to-apply.html

Project Updates TELE-REHAB Closed to Enrollment: Study Updates: Study Project Managers: Lucy Dodakian, MA, OTR/L Judith Spilker, RN, BSN Study Investigator: Steve Cramer, MD Data Manager: Kavita Patel

Project Updates i-DEF Closed to Enrollment: Study Updates: Study Project Manager: Jessica Griffin Study Investigator: Magdy Selim, MD

Project Updates DEFUSE 3 Closed to Enrollment: Study Updates: Study Project Manager: Stephanie Kemp, BS Janice Carrozzella, MSN, CNP, RT(R), CCRA Study Investigator: Greg Albers, MD Data Manager: Jessica Griffin

Project Updates CREST 2 Study Updates: Study Project Manager: Mary Longbottom, CCRP, CREST Director for Data Quality  Study Investigator: Tom Brott, MD

Project Updates ARCADIA Study Updates: Study Project Manager: Irene Ewing, RN, BSN Study Investigator: Hooman Kamel, MD; Mitch Elkind, MD Data Manager: Faria Khattak

ARCADIA Site Readiness update CIRB submissions-60 sites CIRB Approvals-46 sites Readiness Calls-22 sites Released to enroll-17 sites

ARCADIA Enrollment Update Consented/Enrolled-16 subjects Randomized- 2 subjects Screen failure logs submitted- 65 (due on the 10th of the month) For Eligibility questions email the PIs at arcadia@ucmail.uc.edu or call the ARCADIA hotline 1-833-427-2234.

Core Eligibility Criteria Central lab – NT-proBNP/Biobank- notify when sending, include copy of CRF 503 ECG-De-identify prior to uploading! Echo- Site enters atrial diameter results- WebDCU™ will calculate the atrial index- Save on DVD, de-identify and batch shipments. Eligibility/Randomization Email notification of subject eligibility Sites can check subject eligibility status in WebDCU under to Project status/Subject status Result of BNP will be visible after randomization

Please invite your pharmacist to join your readiness call. Pharmacy The pharmacy license and a pharmacist license are needed to ship the study drug to your site. Be sure to have an address listed in WebDCU™ for this as well as Lab kits. Consider listing more than one pharmacist on your DOA so there are multiple people who can accept study drug shipments. Please invite your pharmacist to join your readiness call. Pharmacy video is posted on the WebDCU™ campus training site If your site is not planning on having study drug shipped to an actual pharmacy, notify us now and we will send you a checklist that will walk you through what we need to do to ensure the alternate shipping location is allowable.

Project Updates Sleep Smart / MOST Project Manager: Teresa Murrell-Bohn Iris Deeds Sleep Smart: Manager: TBD

Project Updates Recognized NIH Trials That remain open to enrollments: Study Updates: SHINE Project Manager: Heather Haughey

NCC/NINDS Updates (Forum for CC to communicate to coordinators information on reminders, common questions/issues, changes, suggestions, best practices, upcoming meetings, and for coordinators to ask questions): NCC Staff Members: Joe Broderick, PI Jamey Frasure, Co-Director Judith Spilker, Co-Director Sue Roll, CIRB Liaison Keeley Hendrix, CIRB Diane Sparks, Contracts Jeanne Sester, Training Coordinator Mary Ann Harty, Finances Rose Beckmann, Administration Joanna Vivalda, NINDS Scott Janis, NINDS

Data Management Center Updates (Forum for MUSC to communicate to coordinators information on reminders, common mistakes, changes, suggestions, best practices and for coordinators to ask questions): WebDCU/MUSC Team: Yuko Palesch, PI Wenle Zhao, PI Catherine Dillon, Operations Mgr. Jessica Griffin, Project Mgr.

CIRB Updates CIRB Team Members: Sue Roll, CIRB Liaison Keeley Hendrix CIRB Coordinator Jo Ann Behrle CIRB HPA

Roundtable Discussion Today’s Roundtable Discussion: “QAR Reporting” Making it Better and Easier  Today’s Host: Stephanie M. Wilbrand, PhD Clinical Research Manager Department of Neurological Surgery University of Wisconsin – Madison

Stephanie M. Wilbrand, PhD

Quarterly Activity Reports – best practices Know what everybody in your RCC does PI(s) Co-PIs Collaborators Satellites Study coordinators Fellow/Trainees Researchers, etc. Have a good relationship with faculty administrative support I talk to them daily/weekly Have them forward you faculties completed activities Keep a checklist of all activities that your RCC needs to complete Weekly meeting PI and Research Program Manager

Quarterly Activity Reports – best practices Keep a list of activities throughout the quarter – both Jen and I keep logs

I add all StrokeNet activities to my calendar – mark different colors Quarterly Activity Reports – best practices I add all StrokeNet activities to my calendar – mark different colors

Quarterly Activity Reports – best practices Once one is completed I add it to QAR template

Quarterly Activity Reports – best practices Quarterly reminders in calendar Set reminder in you calendar a month before to collect information Start asking for information that is missing Set another reminder when the quarter has ended Set another reminder 1-2 weeks before deadline

Quarterly Activity Reports – best practices Compare your checklist with metrics send by the RCC List everything including cancelled calls/webinars – mark them as cancelled Follow chronological order Add items in groups When submitting email the QAR to NCC and post on intranet immediately

Quarterly Activity Reports – best practices

Thank you

General Information and Reminders Help Wanted: Presenters for upcoming meetings/Coordinators Calls. Next call any RCC manager wants to share insights. No Montreal Managers Breakout Session. Upcoming Polling questions for next months call. Per Joanna Vivalda, RCCs will need to submit a Final-RPPR no later than 120 calendar days from the period of performance end date (7/31/2018).  Earlier in the window is preferred for centers that will receive an award as an RCC for the 2nd cycle of NIH StrokeNet. QAR Due 4/1/18