VAIRRS Monthly Webinar August 15, 2023 Summary

VA Innovation and Research Review System (VAIRRS) Monthly Webinar August 15, 2023 1

Webinar Housekeeping Webinar Webinar Housekeeping Housekeeping Q&A - Please use the Q&A feature to submit questions. Be sure to send questions to All Panelists Questions will be addressed at the end of the webinar Webinar Archive - Most ORPP&E webinars can be found here: https://www.research.va.gov/programs/orppe/educati on/webinars/archives.cfm Post-Webinar Evaluation Survey - We are grateful to everyone who completes the post-webinar evaluation survey, which will automatically pop up once the webinar is exited. Recording - This session is recorded, and the associated handouts will be available on ORPP&E s Education and Training website within a week after the webinar. Close Captioning - Now available in the new Webex platform. Click the CC button at the bottom left of the Webex screen. Experiencing Sound Issues? - Call in using the number in your Webex chat box or in your registration confirmation email. 2

Contents 01 Welcome 02 Announcements 03 VAIRRS Monthly Webinar Series: New Wizards Presented by: Angela Foster, Program Manager Q&A Panel: Tony Laracuente, Director of Field Operations Christina Bennett, Health System Specialist, VA Northeast Ohio HCS Jessica Kroll, CIRB IRB Administrator Jennifer Ordman, Health Science Specialist, Hines VAMC 3

Important Announcements IRB Information Sheet Wizard Update VAIRRS University VAIRRS Change Control Board VAIRRS University has added a new Spotlight feature to highlight the latest program updates. You ll find links to What s New , as well as the latest VAIRRS webinar and newsletters all in one place. If you would like to learn more about VAIRRS University, the recording of the VAIRRS University walk-through webinar is available. The presentation is led by VAIRRS experts who dive into the details of the new training library. Have you checked your sites' IRB Information Sheet wizard completion rate recently? As of now, we have reached a 68% completion rate. As a reminder, all human research projects must complete the IRB Information Sheet wizard. Projects under the oversight of an affiliate or external IRB are also expected to complete this wizard. Please continue to work with your investigator community to ensure awareness of the IRB Information Sheet requirement. Thank you! During the May/June Change Control Board meeting the following forms were updated/added to the ORPP&E Standard Form Library on IRBNet and on SharePoint. 3.16L Directors Certification International Research 3.17L Directors Certification Pregnant Women 3.18L Directors Certification Children 3.81L Directors Support Prisoners 2.1 Request for Waiver of HIPAA Authorization 7.18R Reviewer Checklist Amendment 7.19L IRB Amendment Approval Expedited Convened Letter Template Subscribe to the VAIRRS Newsletter to keep up with important announcements and program updates: https://public.govdelivery.com/accounts/USVHA/subscriber/new?topic_id=USVHA_1952 4

VAIRRS Monthly Webinar Series: New Wizards Presenter: Angela Foster, Program Manager, Enterprise Research Data Systems Q&A Panel: Tony Laracuente, Director of Field Operations Christina Bennett, Health System Specialist, VA Northeast Ohio HCS Jessica Kroll, CIRB IRB Administrator Jennifer Ordman, Health Science Specialist, Hines VAMC 5

Overview 6

What is New? Three new wizards are in development to streamline investigator and study team tracking, and ERDSP submission and review. New Wizards Investigator Tracking Wizard Study Team Tracking Wizard ERDSP Wizard 7

What Changed? The Project Cover Sheet wizard was updated, and the personnel tracking section was removed. The IRB Information Sheet wizard was updated to include additional fields and clarify questions. Updated Wizards Project Cover Sheet Wizard IRB Information Sheet Wizard 8

Benefits of New Wizards and Changes Improve business processes across all VA research programs Ensure wizards included fields that are in accordance with regulatory guidance Reduce the burden of personnel and study team tracking process Decreases burden of updating multiple systems/templates for research project and investigator tracking 9

New Wizards 10

Investigator Tracking Wizard The Investigator Tracking wizard is for investigators only and includes information previously tracked in the ePromise Investigator Profile. The Investigator Tracking wizard must be completed and submitted to the local research administration for new investigators and updated annually, or if any changes affect information provided in the form. Annual updates can be completed using the wizard clone function. The wizard is expected to deploy in September 2023. VAIRRS will communicate the requirement to the investigator community and provide support (webinars, office hours, and help desk support) to investigators should they have questions or require assistance. The wizard is organized by four logic-based pages which includes: Page 1: VA Investigator Details Page 2: Investigator University Appointment Page 3: University Appointment Details Page 4: Research Interests and Specialty This data collected in this application supports metrics reporting at the medical center level and national reporting for the Office of Research and Development (ORD). 11

Investigator Tracking Wizard Walk-through Investigator Tracking Wizard 12

Study Team Tracking Wizard The Study Team Tracking wizard is for study team tracking and includes Financial Conflict of Interest and Outside Compensation (new!) reporting. The Study Team Tracking wizard is expected to deploy in September 2023. The Study Team Tracking sheet must be submitted with new study applications or at the time of continuing review/annual update, when any changes to the study team affect information provided in the previously completed Project Cover Sheet wizard, and for annual updates to the outside compensation reporting requirements. Annual updates can be completed using the wizard clone function. VAIRRS will communicate the requirement to the study teams for active projects and provide support (webinars, office hours, and help desk support) should there be any questions or need for assistance. The wizard is organized by six logic-based pages which include: Page 1: VA Project Lead/ Principal Investigator Page 2: EHR Access Page 3: VA Project Lead/ Principal Investigator (logic based) Page 4: Additional Project Personnel (optional) Page 5: Additional Project Personnel EHR Access (logic based) Page 6: Additional Project Personnel FCOI (logic based) This data collected in this application supports metrics reporting at the medical center level and national reporting for the Office of Research and Development (ORD). 13

Study Team Tracking Wizard Walk-through Study Team Tracking Wizard 14

ERDSP Wizard The Enterprise Research Data Security Plan (ERDSP) is a standardized data security plan template designed to provide VA Research & Development (R&D) stakeholders (VA Investigators, Information System Security Officers (ISSOs), Research Coordinators, Research Administrative Officers, Research Compliance Officers and Institutional Review Boards (IRBs)) with a tool to aide in documenting the safeguards to protect research data, information and resources. The Office of Research Reviews (ORR) is also converting the ERDSP into a wizard! The ERDSP wizard will replace the current template. More information regarding the wizard and related requirements will be provided by O&IT s Office of Research Reviews (ORR). 15

Updated Wizards 16

Project Cover Sheet Wizard The Project Cover Sheet wizard is what drives most of the metrics needed for the research enterprise dashboards. The data collected in the wizard feeds the local and ORD dashboards. Notable Changes: Personnel Tracking Section removed from wizard FCOI/COI Disclosure removed from wizard 17

IRB Information Sheet The IRB Information Sheet wizard is required of all projects that are submitted to an IRB. IRBNet collects data from completed IRB info sheets and produces a series of data exports, which are used in the development of the dashboards. Notable Changes: Updated language and titles to be inclusive of multi-site/CIRB studies Updated Local Site Investigator (LSI) logic in the wizard Additional fields to meet regulatory guidance and improve business workflows Draft is available in the sandbox! 18

IRB Information Sheet Demo 19

Resources Investigator Details Wizard Outline Study Team Tracking Wizard Outline Project Cover Sheet Wizard Outline IRB Informational Sheet Wizard Outline 20

Thank you for joining! If you have any questions, please contact the VAIRRS Support Team at VAIRRS@va.gov 21