PCS Wizard Completion Campaign

Thanks to your effort and commitment, we have reached a 70.9% completion rate for Project Cover Sheets (PCS). The PCS completion rate began at 32% back in October 2021 and in less than a year, more than 7,000 cover sheets have been completed! Please continue to work with investigators at your site to ensure wizards are completed for all new study submissions and all active projects that have transitioned to IRBNet.

DATA SHOUTOUTS

COVID-19 Research Dashboard

Nearly 900 COVID-19-related research projects were submitted to VAIRRS and can be easily tracked via our COVID-19 Research Dashboard.

In response to the COVID-19 pandemic, VA has managed the review of hundreds of research projects using VAIRRS. The dashboard allows users to find studies on specific topics and locations. An interactive map featured in the dashboard shows active VA studies on COVID-19, and users can quickly and easily search to find studies by specific topics and/or locations.

The COVID-19-related projects submitted to the VAIRRS platform support and advance VA's clinical and research missions, ultimately helping Veterans affected by the disease.

DID YOU KNOW?

VAIRRS Strategic Advisory Council

VAIRRS Change Control Board 

Effective on September 6, 2022, the VAIRRS Change Control Board (CCB) intake process has been updated. Moving forward, all change requests must be submitted through the VAIRRS SharePoint CCB Requests link (click here). We are no longer accepting change requests via the VAIRRS inbox.

COI Module

The Conflict of Interest (COI) module is currently under development with an expected deployment date of October 2022. Please complete the COI Administrator Data Call Response form or forward responses to your COI administrator.

VAEDA

VA Box.Com 

Available to your team now!  

VAIRRS AMBASSADOR - VA GREATER LOS ANGELES HEALTHCARE SYSTEM

VAIRRS Experience:  

In February 2021, VA Greater Los Angeles (GLA) Healthcare System Research & Development announced the transition from iMedRIS to the IRBNet/VAIRRS platform. To assist with the transition, GLA offered seven Microsoft Teams training sessions for their 800+ researchers and staff. All sessions were led by Mr. Cody Knight, the GLA IRBNet administrator, who provided exceptional support and technical assistance. Additionally, VA GLA recorded a training session and made the video available to all researchers and staff via the GLA Internal Research Service SharePoint site for on-demand access with related IRBNet information, walkthrough tutorials and research forms.

GLA’s IRBNet data transition began on March 22, 2021 when ~500 active projects were migrated to the new system. Within the following two weeks, GLA committee coordinators manually uploaded all study documents into IRBNet for these projects, to complete the data migration process and successfully launch their IRBNet “go live” on April 5, 2021. During the first year of GLA’s integration, they prioritized communication efforts to inform their community about IRBNet updates and reminders of important deadlines.

GLA leadership’s (Drs. Linda Demer, Scott Krahl and Taigy Gooding) response to this transition and the skillset and proactiveness of the GLA team (Mr. Cody Knight, Dr. Elizabeth Corey and Dr. Fredricka Martin) were instrumental in helping the facility reach their transition goals within a very short time period. VA GLA also had dedicated committee coordinators, Daniela Macias, Edward Hallisy, Alissa Simon, Margaret Roch, John Berard and Giselle Henry, who made the transition possible. In addition, the VA GLA communications manager, Ms. Cynthia Gammage, played a pivotal role, leading the email, training and SharePoint campaign efforts to keep the community informed.

VA CENTRAL IRB 

Removal of Investigator Signature Line & Admin Updates

The VA Central IRB has removed investigator signature lines from ALL submission forms and made additional minor administrative updates. All updated forms can be found in the VA Central IRB Forms and Templates Library. Please ensure you begin using these new forms for your next Central IRB submission. Beginning Monday, October 3^rd, any package that is received with an outdated form will be returned for the updated form to be completed and uploaded.

Enterprise Research Data Security Plan

The VA Central IRB continues to support the Central ISSO review for multi-site project submissions. Below are useful tips and guidance that can be followed when submitting an Enterprise Research Data Security Plan (ERDSP) for a Central IRB project. 

Research Projects Approved Prior to May 2021: An ERDSP is NOT required for research projects approved by the Central IRB prior to May 2021. However, amendments to research projects approved prior to May 2021 may require an ERDSP. To determine if an ERDSP is required for a protocol amendment, VA investigators must use Appendix B (Research Study Amendment ERDSP Determination Aid) of the ERDSP User Guide. This guide can be found in the IRBNet Forms and Templates Library.

IMPORTANT NOTE: If an ERDSP was never submitted for a project and you are now submitting one for the first time because of a protocol amendment, the entire ERDSP should NOT be completed. In this case, only Appendix B should be completed.

New Research Projects: An ERDSP is required for all new principal investigator/study chair (PISC) and local site investigator (LSI) projects. 

LEARNING CORNER

The Office of Research Protections, Policy, and Education (ORPP&E) is hosting two webinars next week!

TEAM SPOTLIGHT: The VAIRRS Support Team

The VAIRRS Support Team is the driving force, or the "behind the curtain," if you will, of the VAIRRS program. VAIRRS Support is responsible for intake of the VAIRRS@va.gov inbox (200+ emails per month), communications (monthly newsletters, website updates, user guides, webinars), one-on-one site support (6+ facilities), dashboards, CCB support and so much more! When you're struggling with a new platform or looking for a more efficient way to accomplish tasks, the team is here to help! 

"BACK TO BASICS" 

Document Version History 

It is recommended that investigators are instructed to use the pencil icon whenever documents within a package must be updated. The use of the pencil icon enables document versioning within IRBNet. In the event the pencil icon is not used, administrators may enforce document versioning on the designer page using the "drag and drop" function. Instructions are as follows:

1. Click on the document type in the ‘Documents in this Package’ section.
2. While holding down the mouse button, drag the item to the appropriate document in the ‘Documents from Previous Packages’ section.
3. Hover over the paper icon.
4. A pop-up will appear, which reads, "Add to this Document Revision History."
5. Release the mouse button.
6. A second pop-up may appear if the document types are not the same.
7. Select 'Continue.'
8. The document versions will be viewable by clicking the multiple paper icon in the ‘Documents in this Package’ section.

VAIRRS LIBRARY UPDATE

All updated forms will be posted to the VAIRRS SharePoint on September 9, 2022, for review and will be posted to IRBNet on September 30, 2022. The changes include:

• 4.6L IBC Amendment Approval Letter Template - New
• 7.27A IRB Closure Report - New
• 7.13A IRB Continuing Review Application - Revised language and removed investigator signature
• 3.22L RDC Annual Status Acknowledgment - New
• 4.0A IBC Application - Revised guidance and updated links
• 3.6A RDC Continuing Review or Closure - Removed investigator signature
• 3.5A Non-Veterans - Revised language
• 7.2A Combined ICF and HIPAA/7.3A Standalone ICF - Removal of "Date" field in participant section and revised guidance

IRBNet TOPICS

Action: You Spoke, We Listened

CONCERN

Many of our users have found it difficult to locate training resources.

SOLUTION

We are introducing role-based training pathways in fall 2022. Training resources will be categorized by role (administrator, member, investigator) to improve access.

HELP DESK AND TEAM RESOURCES

IRBNet support is available at govsupport@irbnet.org for technical issues and questions related to IRBNet. For regulatory questions or questions about processes subject to regulatory guidance, visit the ORD FAQs page and use the search tools to find the answer. If you still need help, email VAIRRS@va.gov. The VAIRRS User Group Listserv is also available if you would like to reach out to other users. Email the VAIRRS team to be added to the listserv.

Training resources and the VAIRRS Toolkit are available on the VAIRRS SharePoint portal.

The VAIRRS Change Control Board meets monthly to review requested changes and potential new forms and letter templates. Please submit your suggestions through the VAIRRS SharePoint CCB Requests link (click here). Reminder: It is expected that all VAIRRS sites will use the standard library and supplement with local forms as necessary. The Project Cover Sheet and IRB Information Sheet wizards must be completed at the next study event as soon as possible.

LOOKING AHEAD

• COI Module Deployment
• New Training Pathways
• Mentor Recruitment Announcement
• VAIRRS October Webinar

Thank you,

VAIRRS Support Team

VAIRRS WEBSITE:  https://www.research.va.gov/programs/orppe/vairrs/default.cfm

VAIRRS SharePoint:  https://dvagov.sharepoint.com/sites/VHAORPPE/VAIRRS

ORD Policy and Guidance FAQs:   https://www.research.va.gov/resources/policies/faq-search.cfm