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After the launch of the "Data Integrity" page on the Field Staff Reporting (FSR) Dashboard, the Study Tracking Team (STT) wizard completion campaign is transitioning focus to make progress on the new site. Since its launch in June, 58% of Research and Development Committee (RDC) status flags and 24% of IRB risk levels have been resolved. Please visit the "Data Integrity" page to continue rectifying all issues.
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Please note: the "Data Curation" page was changed to "Data Integrity."
"Data Integrity" emails were sent on Thursday, June 20, 2024. We have recently found an error in the number of "RDC Blank Yellow Flags" in the emails; please ignore this stat and head straight to the "Data Integrity" page for the latest details.
There is now a "Pending Reviews" under the "Overall Project Status" to indicate whether something is in pending status. This will automatically rectify a few "RDC Blank Yellow Flags" moving forward. Further development work is pending and may further rectify some issues automatically.
We have recently updated the language "Risk Level downgraded – not allowed" to "Risk Level downgraded – please verify." The program is not enforcing action be taken from a regulatory perspective, but simply providing an observation of what could be an issue. Unfortunately, even after checking "verify," this flag will continually show up even after the weekly refresh. The VAIRRS Support Team is currently working on a solution for end users to provide feedback to the database so that you can "check off" that you have already verified it. In the meantime, please ignore this kind of alert if you have already verified that it is not an issue.
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If you haven't already completed the VAIRRS Data Evaluation Survey, please do so as soon as possible. We request that individuals in the following roles at all VA research sites to please complete this survey:
- Associate Chief of Staff (ACOS)
- Administrative Officer (AO)
- Administrative staff
The data collected will help shape the future of the VAIRRS program as we continue to enhance our services and support for all VA research sites.
A targeted email was sent to administrators at all sites on June 3, 2024. If you did not receive the email, please click the button below, “Complete Survey.” Also, be sure to update the VAIRRS Distribution subscription list, so that you can receive important surveys and updates in the future.
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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 or becoming a VAIRRS mentor, access the mentee/mentor applications via the VAIRRS Mentor Program SharePoint page. Applications for mentees are accepted on an ongoing basis throughout the year. Applications for mentors are accepted on an ongoing basis until all slots are filled.
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DID YOU KNOW?
Office of Research Reviews (ORR) Updates
VAIRRS, in collaboration with the VA Office of Information Security (OIS), Specialized Device Cybersecurity Department (SDCD), and Office of Research Reviews (ORR), would like to announce the development and release of the Enterprise Research Data Security Plan (ERDSP) Smart Form. On August 1, the ERDSP Smart Form will be available across VA in VAIRRS and should be used for obtaining centralized information security review from ORR. The ERDSP Smart Form replaces the existing PDF with a standardized, step-by-step mechanism for VA investigators to document their plans to protect research information and VA data from risks. While multiple tool tips and various instructions are embedded within the form to assist with proper completion, ORR is working with the VAIRRS team to make training and informational materials about the ERDSP Smart Form available within VAIRRS.
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COI Module
Important note: The COI status indicator (triangle next to each user’s name) is not intended to reflect the annual due date status. Once the initial COI submission is processed, the status indicator does not change until the next annual COI is submitted. The triangle indicator changes to yellow only after the following year’s COI has been submitted but hasn’t been processed yet. After it has been processed, the triangle indicator will turn green again.
When you have more than one investigator on a study, and they submitted their first set of COIs in the IRBNet COI module a year ago, and now they are submitting their annual COIs, you must ensure the OGE 450 Alt VA Wizard has been updated appropriately. The COI administrator must verify the "last modified" date on the wizard to make sure it has been updated for the current submission.
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VAIRRS University
This month, VAIRRS added a new guide on data quality metrics and common data discrepancies, to assist administrators/submission coordinators and IRBNet data users with entering and updating review details in IRBNet. This guide also provides recommended guidelines on how to resolve common data discrepancies. Users can access the document within VAIRRS University by navigating to "Additional Resources" within the Training Material Categories section.
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Feedback Survey
The VAIRRS Support Team is in the process of building a survey directly into VAIRRS University to gather user feedback on an ongoing basis. We want to hear about your experience with navigating through the user roles and your assessment of the training resources in VAIRRS. Your responses and insights will help us to identify gaps within VAIRRS University and assist with strategies to improve usability, training content, and engagement. Look out for more information in the coming weeks.
To learn more about VAIRRS University, watch the recording of the VAIRRS University walk-through webinar, led by VAIRRS experts.
For questions about VAIRRS University, contact the VAIRRS Support Team at VAIRRS@va.gov.
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ORPP&E Standard Form Library Updates
During the June Change Control Board (CCB) meeting, the following request was approved.
In the "7.5R Informed Consent Reviewer Checklist," the language under Section 2, item 20 was adjusted from, “If appropriate, is there a statement that a Veteran participant will not be required to pay for care...” to, “If appropriate, is there a statement that a Veteran participant or their insurance will not be required to pay for care...”
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 The VA Electronic Determination Aid (VAEDA) Support Team is excited to announce the launch of the VAEDA SharePoint page. VAEDA is available for all VA facilities. You can access VAEDA here.
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ePROS is hosting a webinar next week!
VAIRRS Webinar Series: Financial Conflict of Interest Module (fCOI)
for Investigators (Session 2)
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Join the July feature of the VAIRRS Monthly Webinar Series for researchers and investigators to learn more about completing the IRBNet COI module. The VAIRRS Monthly Webinar Series offers expert advice, training, demonstrations, and/or direction to the VA research community regarding various VAIRRS topics. |
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Tuesday, July 30, 2024
3:00 PM - 4:00 PM (EDT)
Angela Foster, ePROS Program Manager
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Note: We are now hosting 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.
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 ERDSP Smart Form Launch
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 August Webinar
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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.
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