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As we kick off spring, the Project Cover Sheet (PCS) and IRB Information Sheet (IIS) wizard completion campaigns are transitioning focus to make progress on the Study Team Tracking (STT) wizard. Currently, only 12% of the active projects have completed an STT, and we are striving for 100%!
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During the February Change Control Board (CCB) meeting, the documents listed in the table below have been updated and added to the ORPP&E Standard Form Library within IRBNet and the VAIRRS SharePoint. The next VAIRRS CCB meeting is scheduled on March 21, 2024.
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February CCB Meeting Updates
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Form/Letter/Wizard
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Summary of Changes
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10.0W Project Cover Sheet Wizard
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The PI name was added, in addition to the name of the person/time of last edit, to the wizard PDF output.
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7.2A Combined ICF and HIPAA Template & 7.3A Informed Consent Template
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The word "template" was added in the front of the revision date in the footers within the 7.2A Combined ICF and HIPAA template and 7.3A Informed Consent Form template.
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3.6A – RDC Continuing Review Application or Final Closure (PDF)
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A text field was added to sub-item 7 under Section 2 – Project Status to allow users to provide the reason for closure.
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1IRB Information Sheet Wizard
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Various language changes were made within the wizard; however, the logic of the wizard was not impacted. To see the exact changes made, please refer to the latest version of the wizard outline linked here, or by navigating to the VAIRRS CCB Summary of Changes section within the VAIRRS SharePoint.
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Study Team Tracking Wizard
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Changes made to the wizard include the addition of an "N/A (Not Salaried by VA)" response option to the Outside Compensation question(s) and the addition of Investigator Details, as well as other minor changes. To see the exact changes made, please refer to the latest version of the wizard outline linked here, or by navigating to the VAIRRS CCB Summary of Changes section within the VAIRRS SharePoint.
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The next expired email notification will be sent on June 15, 2024. The expired projects notification is sent to contacts directly from the Research Office Contact Verification SharePoint list. Only primary and secondary site liaisons have permission to access this SharePoint list to make updates. If there is a change in a role in the list, contact your facility's primary or secondary site liaison to update the list.
If your site's site liaison has transitioned, please contact the VAIRRS Support Team Inbox VAIRRS@va.gov for assistance.
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VAIRRS has added a new Project Closure and Withdrawal User Guide for the purpose of walking administrators/submission coordinators through the process of performing a researcher-initiated closure, performing an administrative closure, and withdrawing an erroneous package. Users can access the new guide within VAIRRS University either by selecting the "Administrator/Submission Coordinator" user role or by navigating to the "VAIRRS User Guides" training material category.
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.
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The Office of Research Reviews (ORR) is developing a series of information security instructions to support the research community. To kick off the series, ORR offers detailed instructions on an often-encountered issue delaying review of an Enterprise Research Data Security Plan (ERDSP) - providing full path names of electronic data storage locations.
The mapping of local drives is site specific. For example, the R: drive in Seattle is not the same as Cincinnati's R: drive. To complete an ERDSP for centralized information security review, ORR needs a drive's full path name, not the "R:" or "S:" but rather the more descriptive unique name starting with \\xxxx.va.gov. For anyone struggling with how to find that full path name, ORR has created an instructional document and short video.
Check out the instructions:
ERDSP Providing the Full Folder Path for Mapped Drives.pdf
And the accompanying video:
ERDSP Providing the Full Folder Path for Mapped Drives Video Recording.mp4
As always, ORR is available to provide further clarification or assistance on all ERDSP-related topics. Feel free to let us know of any corrections or other areas of interest at OISISPSSDCDORRRESEARCHREVIEWTEAM@va.gov.
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 The VAIRRS Mentor Program currently has five team members from various roles across the VA providing mentorship, with a backlog of mentees awaiting the availability of a mentor.
We currently have 11 mentor vacancies. Please let us know if you would like to nominate a potential VAIRRS Mentor. Applications are accepted on an ongoing basis until all mentor slots are filled.
If you are interested in helping fellow VAIRRS users, you can access the mentor application via the VAIRRS Mentor Program SharePoint page.
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VAIRRS Experience:
Coatesville VA Medical Center (VAMC) transitioned from an electronic PDF application to VAIRRS in January 2021, after six months of prep to upload studies and train users. Coatesville VAMC provided VAIRRS trainings to all users and offered additional trainings in smaller chunks to committee members and some one-on-one training to investigators, if needed. It was a lot of information presented in a short time, which was hard for some users to fully grasp.
To reduce burden, Coatesville VAMC uploaded studies with the most recent approved package and all current approved versions of documents. A note-to-file was done stating that previously approved documents were stored elsewhere.
Coatesville VAMC created a mock study in the VAIRRS sandbox for committee members to practice reviews and navigate VAIRRS. They do a pre-meeting to go through the review process. A post-meeting is done to address any questions and any possible recommendations for improvement.
Coatesville VAMC has found that incorporating step-by-step screen shots of VAIRRS throughout the local application reduces confusion for the investigators submitting projects.
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Study Team Tracking (STT) is now live! Refer to the Field Staff Reporting (FSR) dashboard "wizards" page to identify which projects have yet to submit an STT wizard.
Upcoming changes to the FSR dashboard include:
- A derived overall Project Status column based on the latest board statuses
- Data curation to show discrepancies or errors in the data to rectify in IRBNet (IRB Project Risk level & Project Status)
- Inclusion of additional project data that may not currently be identified (i.e. board information that show "blank" statuses)
- The addition of PCS CRADA information
- The addition of a new human subject research protocol list to include the following data: date of Initial IRB approval, date of most recent Continuing Review approval, and initial Review Type.
- The expansion of the Review Tracking data beyond 5-months and 1-year
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The VA Electronic Determination Aid (VAEDA) is available for all VA facilities. You can access VAEDA here.
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VAIRRS is reorganizing its approach to webinars to provide more effective valuable information to the field. Tune in to the VAIRRS April Program Update and the Learning Calendar on the VAIRRS SharePoint to see when our next webinar will be scheduled.
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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 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. 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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Thank you,
VAIRRS Support Team
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