Coordinator Webinar and Round Table Discussion SEPTEMBER 25, 2019 Coordinator Call Announcements and Reminders Next Coordinator Call November 13th, 2019 Todays 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. TBD 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 CREST H CREST H PIS: Randolph Marshall, MD Ron Lazar, PhD David Liebeskind, MD E. Sander Connolly, MD Project Managers:
Jaya Vijayan, CCRC Mayo Clinic Kevin Slane Columbia University 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 ARCADIA-CSI ARCADIA-CSI PIs: 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 Sleep SMART Sleep SMART PIs: 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: MBA Regulatory Specialists: Emily Stinson, MS Diane Sparks, RN, BS Jennifer Golan, MS Wren Hanson, 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 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 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 Childrens Hospital & The Ohio State University, Columbus, OH Fralin Biomedical Research Institute, Virginia Tech, Roanoke, VA Laura Bateman, Study Coordinator [email protected] National Coordinating Center Kim Bernstein Project Manager [email protected]
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 Site Monitoring Manager: Aaron Perlmutter FAQ:
Reimbursement for the Participant Pregnant Partner ICF Approved PP ICF is housed at the NCC. If you need it, we can send MOP and other study specific documents The amount and method of payment a site reimburses for participant transportation is up to the site WebDCU Toolbox
Per patient Budget http://www.nihstrokenet.org/aspire-trial/resources Click on SOW Payment Schedule 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
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
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 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 Todays Topic: Presenters: Cincinnati Regulatory Updates Emily Stinson,, MS University of Jennifer Golan, MS University of Cincinnati 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. 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
COIs 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 COIs 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. 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 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 (2018-0464C-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. Helpful Tips Communication Email subject line (Trial name, Site name, subject)
Please do not combine studies into one email Please do not combine sites into one email 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 Helpful Tips WebDCU Initial email 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 wont 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 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
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