|
 Have you checked your site's Study Team Tracking (STT) Wizard completion rate recently? As of now, we have reached a 21% completion rate. Please continue to work with site administrators to ensure all STTs are submitted. Thank you!
|
|
IRBNet Financial Conflict of Interest (FCOI) Module
VHA Directive 1200.13, published May 2, 2024, requires use of the IRBNet COI module for submission of the Financial Conflict of Interest (ALT-450). The Office of Research & Development (ORD) will host a webinar on June 18, 2024, at 2:30 PM EDT to discuss implementation and training. IRBNet will host training webinars for FCOI administrators over the summer. The VAIRRS Support Team is also available to assist the research community at VAIRRS@va.gov.
|
|
|
The VAIRRS governance boards voted to develop an Administrative Checklist Wizard and Continuing Review/Closure Wizard. The Administrative Checklist will be the first board-facing wizard and will support administrative review. We will keep you updated on our progress over the summer. Email the VAIRRS Support Team at VAIRRS@va.gov for more information or if you would like to participate in the development process.
|
|
|
ORD leadership is looking to assess the field's level of confidence in the completeness and accuracy of the research data within VAIRRS. This survey will also collect pertinent information that will feed into VAIRRS strategy for 2024-2028. The VAIRRS Data Evaluation Survey will serve as the mechanism to collect data from the perspective of each VA research program.
Starting on June 3, 2024, VAIRRS will begin distributing the VAIRRS Data Evaluation Survey via email to research program administrators, Associate Chiefs of Staff (ACOS), and Administrative Officers (AOs). Facilities may have multiple submissions based on the roles at the facility. VAIRRS will also conduct randomized interviews with facility research programs to gather data. If your facility is selected for an interview, the VAIRRS Support Team will reach out to coordinate. Facilities have until July 26, 2024, to submit their survey responses. We appreciate your participation in advance!
|
|
ePROS Standard Form Library Updates
During the April Change Control Board (CCB) meeting, the following requests were approved.
April CCB Meeting Updates
|
Form/Letter/Wizard
|
Summary of Changes
|
Study Team Tracking Wizard
|
Option “g” under the Delegation of Duties section will be adjusted from “prescribe or provide treatment or study intervention (if drugs, list on 10-9012)” to “prescribe or provide treatment or study intervention (if investigational drug(s) without a package insert, list on 10-9012).”
|
7.2A Combined ICF and HIPAA
|
Sample text related to optional banking was removed from page 16.
|
IRB Information Sheet Wizard
|
The Schedule and Amount of Payments text box will be shifted from a plain text response to a rich text response.
|
|
|
VAIRRS University added a new energizer titled, "IRBNet Training Energizer – Submission Coordinator Other Tools_04.2024," which highlights recent updates by IRBNet to the Attendance page of the Minutes Builder. Users can now copy attendance from a previous minutes document, as well as save multiple default sets of attendance lists for use in future minutes. These changes will make it faster for users to complete the Attendance page, as all attendees and designations can now be copied and reused across multiple minute documents.
Users can access the energizer by clicking here, or by going to VAIRRS University and navigating to “IRBNet Energizers” under the Training Material Categories. Once the list of resources loads, users can scroll down or use the search bar to locate the document.
To learn more about VAIRRS University, view the VAIRRS University walk-through webinar, led by VAIRRS experts.
For questions about VAIRRS University, contact the VAIRRS Support Team at VAIRRS@va.gov.
|
|
|
In a recent milestone, the ORR successfully piloted a Centralized Information Security Review (CISR) process with the National Cancer Institute and VA Interagency Group to Accelerate Trials Enrollment (NAVIGATE). As part of this pilot, ORR prepopulated trial-specific Enterprise Research Data Security Plan (ERDSP) templates for select research projects. The prepopulated ERDSP templates were made available to participating NAVIGATE sites through a custom document library in ORR’s public workspace in VAIRRS/IRBNet.
Using the Forms and Templates library functionality in VAIRRS, ORR established a centralized repository for project-specific documents and pertinent Standard Operating Procedures (SOPs) or guidance documents. This repository allowed researchers to easily access the ERDSP needed for their research and to provide only site-specific information, such as document storage location, leading to a more efficient submission and review process.
As ORR celebrates this accomplishment and possibly a new precedent in centralized information security reviews, we look forward to continuing work with NAVIGATE to enhance the established process and assist similar groups in the VA research community who may need centralized information security review.
To request more information about the CISR process or recommendations on additional topics, email the Research Review Team at OISISPSSDCDORRRESEARCHREVIEWTEAM@va.gov.
|
|
|
The dashboard team is preparing to roll out two new pages by the end of May: Site Audit and Data Integrity. The Site Audit page can be used to quickly find relevant information to support a site audit. The Data Integrity page will include data inconsistencies or issues based on the project statuses of various boards, IRB project risk levels, and project expiration dates. Then, individual sites can make updates based on the data integrity issues highlighted on the Data Integrity page. |
|
|
The VAIRRS Mentor Program currently has four team members from various roles across VA providing mentorship, with the ability to support more mentees.
If you are interested in getting help from a fellow VAIRRS user, access the mentee application via the VAIRRS Mentor Program SharePoint page. Applications are accepted on an ongoing basis throughout the year.
|
|
|
VAIRRS Experience:
The VA Phoenix Health Care System (HCS) research transition to VAIRRS started in 2020 and went live in spring 2021. Research staff prepared for the transition by copying pertinent documents for ongoing studies from a customized VA SharePoint database into VAIRRS and provided ongoing training to the research community. To date, VA Phoenix HCS has continued with training, currently offering weekly VAIRRS Q&A sessions developed and led by the R&DC Coordinator to committees and investigators. The Q&As facilitate their continuous effort to update guidance and reference documents for study teams, ultimately creating a dynamic improvement culture.
In early 2023, the COI administrators implemented the COI process through VAIRRS and provided in-depth training sessions to research staff, committees, and investigators prior to full implementation. Additionally, the VA Phoenix HCS Personnel and Training Manager transitioned managing the staff training records from an internal database to VAIRRS.
|
|
Friendly reminder that the COI and RCO Modules are available for all facilities to use. If your facility is interested in adopting either module, please reach out to IRBNet Support at govsupport@irbnet.org.
|
|
|
Back to Basics
|
Umbrella Protocols
|
|
New guidance has been published in VAIRRS University for the submission, review, and tracking of umbrella protocols in IRBNet.
|
|
Research Institution Affiliations
|
|
Investigators can affiliate themselves with multiple VA research institutions within the User Profile section of IRBNet. Once they affiliate themselves with the new institution, investigators should be sure they select the correct research institution when creating a new package. Investigators may need to search for the correct board if it does not show as a default when submitting a package.
|
|
|
The VA Electronic Determination Aid (VAEDA) is available for all VA facilities. You can access VAEDA here.
|
|
|
|
ePROS is hosting a webinar next week!
|
|
Topic: VAIRRS Data Webinar Series: Introduction to the VAIRRS Data Integrity Initiative
Date: Tuesday, May 28, 2024
Time: 2:00 - 3:00 PM (EDT)
Purpose: Join the May feature of the new VAIRRS Data Webinar Series to learn more about the VAIRRS data integrity initiative and its potential impact on your program. The VAIRRS Monthly Webinar Series offers expert advice, training, demonstrations, and/or direction to the VA research community regarding the various topics around VAIRRS.
Lead Presenter: Angie Foster, ePROS Program Manager; VAIRRS Support Team
Note: We are now providing our trainings in MS Teams and you no longer have to register to join an event. Please hold the date/time on your calendars with the link provided below if you would like to join.
CLICK HERE TO JOIN THE MEETING
|
|
|
|
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 Policies and Guidance. 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. If you wish to submit a change request, visit the VAIRRS CCB Request Form. Reminder: It is expected that all VAIRRS sites will use the standard library and supplement with local forms as necessary. The Project Cover Sheet, IRB Information Sheet, and Study Team Tracking wizards must be completed at the next study event as soon as possible.
|
|
|
JUNE TOPICS
- VAIRRS Data Evaluation Survey Launch
- June Webinar
|
|
|
Thank you,
VAIRRS Support Team
|
|
|
|
|
