VAIRRS Program Update | December 2024

VAIRRS Data Integrity

VAIRRS data integrity continued to improve in November. The "Data Integrity" page on the Field Staff Reporting (FSR) Dashboard provides each VAIRRS site with the data and tools needed to ensure the accuracy, completeness, consistency, and reliability of their program’s data. To date, 49% of overall project status flags and 54% of institutional review board (IRB) risk level issues were resolved since the launch of the "Data Integrity" page in June 2024.

Please Note: Overall project status includes the Research and Development Committee (RDC) blank yellow flags. Overall project status flags occur when a project's status is inconsistent with boards outside of the RDC. IRB issues occur when a discrepancy exists between IRB status and risk level.

The goal of the VAIRRS team is to remove all flags and issues within the system to ensure VA researchers have access to the most accurate data. On Thursday, November 21, “Data Integrity” emails were sent to research sites, detailing new issues and flags that have appeared in the system since last quarter. On Friday, December 6, a follow-up email was sent with available VAIRRS data integrity resources to help users amend the issues/flags. Help us improve data integrity. Please continue to review any overall project status flags on an ongoing basis and send them to reviewers or committees to make the necessary updates. Visit the FSR Dashboard and use the left-hand navigation section to see your site's "Data Integrity" page.

We are continuously working to improve the "Data Integrity" page on the FSR Dashboard to enhance and facilitate the user experience. If you would like to speak with the dashboard team about a particular data insight relevant to a specific business need, please do not hesitate to reach out.

DID YOU KNOW?

ERDSP Wizard

The Enterprise Research Data Security Plan (ERDSP) Wizard in VAIRRS streamlines the process for obtaining centralized information security reviews from the Office of Research Reviews (ORR). The ERDSP smart form provides a mechanism to account for the security of research protocol data during each stage of the data management life cycle while ensuring consistent evaluation of a research protocol’s data usage, storage, sharing, and transmission methods.

Required for use since November 1, 2024, specifically for new submission, amendment, or administrative updates, the following changes were made to the wizard on November 7, 2024.

• Enabled PIs to specify when they add new participating sites and list them
• Required LSIs to complete the following sections:
  • Section IV. Information Sharing
  • Section VII. Websites and Cloud-Based Software
  • Section VIII. Mobile Devices and Portable Storage Devices

• Added clarifying text to the completion page on saving instructions and finding the ERDSP in the package documents

With the ERDSP in a wizard format, it can be shared for cloning, such as from a PI to participating LSIs. It is strongly recommended that the ERDSP be reviewed and approved before sharing to avoid duplicating issues.

To assist investigators during the transition process, please review ORR’s quick reference guide, which includes support links to training and additional resources.

Please view the ERDSP Wizard Training Webinar to learn more about the wizard.

Questions related to the ERDSP and Information System Security Officer (ISSO) review should be directed to the following email address: OISISPSSDCDORR@va.gov.

ORPP&E Standard Form Library Updates

VAIRRS approved five change requests during the November Change Control Board (CCB) meeting. Updates to wizards are implemented on a quarterly basis.

REQUEST FOR FEEDBACK:

The 4.1L IBC Initial Approval Letter and the 4.2L IBC 3 Year Approval Letter have recently been updated to include an important new statement, which will be added as item no. 3 within both forms: “Procedures at the BSL [x] level have been approved for this protocol.” The VAIRRS team encourages you to take a moment to review these changes and share your feedback. Your input is greatly appreciated!

Data Dictionary Workgroup

VAIRRS will establish a standardized version of the VAIRRS Data Dictionary. We are requesting assistance from the field in this effort. A current version of the Data Dictionary is available through VAIRRS University. A workgroup will begin in the new year, with a proposed first meeting date of Tuesday, January 28, 2025, at 2:30pm ET. If you would like to participate in this workgroup, please send an email to the VAIRRS Support Team by January 10, 2025.

VAIRRS University As the year comes to a close, your feedback is crucial to ongoing VAIRRS efforts that further enhance VAIRRS University. We encourage you to participate in the VAIRRS survey and share your insights by clicking the "Share Your Experience" button below or visiting the VAIRRS University SharePoint page (VA access only). Your input will help VAIRRS identify gaps and improve usability, training content, and engagement within VAIRRS University throughout the next year.

For questions about VAIRRS University, contact the VAIRRS Support Team.

Million Veteran Program (MVP) Update

The VAIRRS team is excited to announce a streamlined submission and review process for MVP Feasibility Requests. The streamlined guidance, “Guidance Document for MVP Feasibility Request Process for VA Investigators” (link goes through the ORD intranet funding site), replaces the current guidance version (2/14/2024) and can also be found in the VHA ORPPE&E library for human subjects researchers.

A few things to highlight about the updated guidance:

• There is a new online submission platform for MVP Feasibility Review Form - Power Apps.
• Every new submission and resubmission using MVP data must submit an MVP feasibility Request form and submit the Approval Memo with the funding application.
• Certain supplemental funds are allowed for existing MVP projects.
• Non-VA federal funding must be administered by the local NPC.

The VAIRRS team looks forward to seeing an increase in projects utilizing MVP data. For the most updated information, please click the button below for guidance and the full process.

Please direct questions to the following email address.

LEARNING CORNER

VAIRRS is hosting office hours in December!

VAIRRS Office Hours: Data Integrity Issues

VAIRRS is offering office hours to users seeking guidance on correcting issues on the "Data Integrity" page within the FSR Dashboard. 

Office hours offer expert advice, training, demonstrations, and/or direction to the VA research community regarding VAIRRS data integrity.

Wednesday, December 18, 2024
3:00 PM - 4:00 PM (EST)

Angela Foster, ePROS Program Manager
Alex Devine, VAIRRS Support Team

Note: Office hours replace the December VAIRRS Monthly Webinar. Office hours will be hosted via Microsoft Teams. Please hold the date/time on your calendars with the link provided below if you would like to join. 

VAIRRS End User Support Program

The VAIRRS End User Support Team provides administrative assistance to VA research programs to aid in the adoption of VAIRRS, increase compliance with related protocols and directives, and alleviate workload for site administrators. The support team works closely with VA research programs, for an average duration of six to nine months, assisting in pre- or post-submission validation of VA Project Cover Sheets, translation of board actions from a site's local database to IRBNet, consolidation of duplicate projects, and rectification of data discrepancies (yellow overall project status flags). If your VA research program is interested in assistance, please send an end user support request to begin the onboarding process.

2024 WRAP-UP AND 2025 OUTLOOK

Program Highlights

Thank you for your dedication and efforts to another successful year! The VAIRRS platform (IRBNet) had more than 40,000 registered users in FY24. Please see below for a few program highlights from 2024 and a peek into 2025.

Mentor Program

Thank you to all who participated in the VAIRRS Mentor Program! This initiative brought together dedicated team members from various roles across VA to provide mentorship and support.

This program, which was successfully concluded in September 2024, featured 5 exceptional mentors who went above and beyond in assisting and training 15 VAIRRS users. Their efforts significantly contributed to expediting best practices at facilities across the country and enhancing the overall VAIRRS experience.

The VAIRRS Support Team is proud to report that the program achieved outstanding results:

• 93% of mentees expressed satisfaction with their overall mentee experience
• 96% of mentees were satisfied with their mentors' knowledge and assistance

To the VAIRRS mentors: Your dedication, expertise, and willingness to share your knowledge has been instrumental in strengthening VA research. Your contributions will continue to resonate throughout the VAIRRS platform and the broader VA research community.

To the VAIRRS mentees: Thank you for your enthusiasm and commitment to learning. Your growth and success are a testament to the program's effectiveness and your own dedication to excellence.

As we bid farewell to the VAIRRS Mentor Program, the VAIRRS Support Team celebrates the connections made, the knowledge shared, and the lasting impact it will have on VA research. Your efforts have truly made a difference!

Field Staff Reporting (FSR) Dashboard

In FY24, the FSR Dashboard had 444 active viewers and more than 9,100 views. In June 2024, the “Data Integrity” page was launched and provided users with the data and tools to resolve 53% of IRB risk level issues and 44% of RDC status flags.

VAIRRS Ambassador/VAIRRS Enterprise Partnership Award Highlight

Thank you to all VAIRRS Ambassadors for their dedicated service! Each participating site was committed to improving the system and contributed to the benefits the VAIRRS enterprise offers. Their efforts have been invaluable in shaping and enhancing our research processes.

As we wrap up 2024, the VAIRRS Ambassador Program will also come to an end. The impact of the VAIRRS ambassadors will continue to resonate throughout the VA research community. Thank you for your passion, expertise, and tireless efforts in advancing VA research through the VAIRRS platform.

VAIRRS 2024 Ambassadors:

• VAIRRS March Ambassador: Coatesville VA Medical Center
• VAIRRS May Ambassador: VA Phoenix Health Care System

Congratulations to the 2024 VAIRRS Enterprise Partnership Award (VEPA) winners! The VEPA recognizes VA research programs that exceed requirements and have fully transitioned to VAIRRS to meet enterprise standards established by the Office of Research and Development (ORD). The VEPA recognizes VA research programs by size (small, medium, and large) and annually awards three programs based on their completion metrics and positive contributions that enable the expansion of the mission and priorities of both VAIRRS and ORD.

VAIRRS 2024 VEPA winners:

• VA Atlanta Healthcare System (Large)
• VA Phoenix Health Care System (Medium)
• VA Salem Healthcare System (Small)

VAIRRS Data Evaluation Survey Completion

The VAIRRS team completed 142 surveys from June – August 2024, including 18 total interviews with research sites performing in the top and bottom 10%. There was also a 77% survey penetration rate with 85 unique VA Research Sites represented in the survey. Thank you very much to all those who have participated and helped in providing crucial data to enhance our resources in 2025! 

VAIRRS University

VAIRRS created 10 short videos to support dashboards. The team added 55 resources in FY24. Resources include best practices, navigational guides, checklists, and tutorials. In 2025, VAIRRS will launch a public-facing version of VAIRRS University, in addition to the SharePoint version.  

VAIRRS Best Practice Sandbox (BPS) Soft Launch

The VAIRRS BPS soft-launched in November 2024. The BPS is designed to serve as a collaborative platform for the field to share local research-specific VAIRRS processes and best practices, as it relates to IRBNet, with the larger VA research community. VAIRRS is conducting a soft launch to test and collect feedback on the BPS platform and processes. In 2025, VAIRRS will officially launch the BPS.

VAIRRS Webinars

VAIRRS hosted 8 webinars, averaging 281 attendees per webinar. The VAIRRS Webinar Series offers expert advice, training, demonstrations, and/or direction to the VA research community regarding various VAIRRS topics.

LOOKING AHEAD

December Office Hours

January VAIRRS Webinar

We appreciate your continued commitment to excellence in VA research. The VAIRRS newsletter will return next month with the latest updates and information. We look forward to sharing more with you soon.

Thank you,

The VAIRRS Support Team

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