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We are quickly approaching the 70% completion milestone for Project Cover Sheet (PCS) Wizards! 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.
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As of July 8, 2022, we have completed 11,775 Project Cover Sheets, accounting for 68.8% of the 17,116 active projects.
If you have questions regarding PCS, reference the VAIRRS FAQs or contact VAIRRS@va.gov.
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1) What are the benefits of the RCO module?
RCOs will be able to easily and automatically access the electronic records they need, record audit results using the electronic audit tools, and automatically have VA committees and researchers properly notified and provided with access to the audit results. At the end of the 2022-23 reporting cycle, IRBNet will provide RCOs with aggregate data supporting that cycle's Facility Director Certification (Part B) report.
2) Will RCOs be required to use the new module?
For IRBNet to provide an RCO with the aggregate data, and for the data to be accurate, the RCO must record all of their audits for the reporting cycle within IRBNet using the electronic tools. The oversight committee may request RCO audits be submitted using the RCO module. ORO strongly encourages using the new module.
3) Will the new module create more work for the RCOs?
No. The RCO module is expected to reduce the amount of work required by RCOs to record and share audit results in IRBNet.
Please visit the VAIRRS FAQs for more information about the RCO workspace.
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Document Finder Tool (DFT)
Coming in early September, ORPP&E will be presenting the ORD Document Finder
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Tool. This application is a one-stop shop to quickly search, browse, filter and view the most current VA research policy and document content. Results will also link to published FAQs by keyword. The Document Finder Tool is currently being utilized by select ORD, ORO and OGC teams and real-time feedback is being collected. Watch for upcoming webinars and launch information!
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About Madison: The William S. Middleton Memorial Veterans Hospital is a mid-sized research program with 158 funded research projects, 71 funded principal investigators and 450 research personnel.
VAIRRS Experience: The Madison VAMC launched VAIRRS in November 2020 as a part of Tier 2. To help investigators through the transition, Program Support Assistant Karen Hoffman and R&DC Coordinator Jamie Swanlund created detailed, user-friendly standard operating procedures (SOPs) and guidance documents. Hoffman recorded a series of how-to videos covering topics, such as registration, creating a new project, creating a new package, responding to package revisions, using project tags, finding board documents after committee reviews, uploading training certificates and project sharing. In addition, to further develop user capabilities and comfort with VAIRRS at the Madison VAMC, Hoffman and Swanlund meet with research teams one-on-one, guiding users through the submission process and assisting with revisions.
Proactive Practices: Research administrative staff conduct a daily VAIRRS huddle to discuss new submissions and keep track of projects to ensure consistency and to enhance teamwork. To further support research study teams, Hoffman and Swanlund have set up semimonthly office hours for drop-in questions and guidance. Additionally, Mina Herreman, our research training specialist, implemented trainings within IRBNet, allowing us to track all team member trainings with each project. It has been a big success for our program and our researchers.
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VA CENTRAL IRB
VA Central IRB Forms Update
The VA Central IRB has removed investigator signature lines from ALL of our submission forms to better align with VAIRRS IRB submissions forms. All updated forms can be found in our VA Central IRB Forms and Templates Library. Please ensure that you start using the new forms for your next Central IRB submission.
IRBNet Package Signature
The VA Central IRB requires that the investigator (or designee) sign the package in IRBNet for new project submissions only. All other submission types do not require an investigator (or designee) signature but can be signed by other study team members. Please note that this may differ from your local research administration requirements.
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LEARNING CORNER
The Office of Research Protections, Policy, and Education (ORPP&E) is hosting a webinar:
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Topic: VAIRRS Monthly Webinar - VAIRRS Ambassador Highlight: William S. Middleton Memorial Veterans Hospital (Madison VAMC)
Date: Tuesday, July 19, 2022
Time: 2:00 - 3:00 PM (EDT)
Purpose: The William S. Middleton Memorial Hospital is featured as the July VAIRRS Ambassador. Join us for a webinar to learn about the solutions and best practices that the July VAIRRS Ambassador created as they sustain VAIRRS at their facility.
Lead Presenters: Aaron Heneghan, Karen Hoffman, Jamie Swanlund
Target Audience: R&D committee members, IRB members, research office staff, compliance officers, research committee members, investigators and study team members
CLICK HERE TO REGISTER!
*We suggest you log on using Google Chrome or Microsoft Edge.
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"BACK TO BASICS"
Are projects required to be shared with all project team members?
As part of each review process, the subcommittee must ensure that the project has been shared with all project team members. This is important because it affects an RCO's ability to access the complete project record and training information when performing an audit. Project sharing must be consistent with team members reported in the Project Cover Sheet Wizard. All project team members must be shared on the project to link training information, and all project team members must be included in the Additional Personnel section of the Project Cover Sheet Wizard to ensure the appropriate electronic health record (EHR) access is provisioned.
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Thanks to the facilities that have already volunteered for the VA Electronic Determination Aid (VAEDA) soft launch. VAEDA is provided to reduce variability in research determination outcomes and save time and resources in your day-to-day processes. We are excited to launch this program to improve the efficiencies of VA Research enterprise operations. If your facility is interested in participating in the soft launch of VAEDA, please email VAEDAsupport@va.gov.
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IRBNet TOPICS
Action: You Spoke, We Listened
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Committees have reported difficulty locating the most recently approved study documents in IRBNet. |
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The June VAIRRS Monthly webinar focused on "Best Practices on How to Track and Locate Approved Documents in IRBNet." Field experts led this presentation based on feedback received thus far. Attendees found the webinar to be very informative and beneficial to their daily practices. If you were not able to attend the webinar, you can find the recorded webinar and presentation slides here. |
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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. Please submit your suggestions to VAIRRS@va.gov. 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.
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Thank you,
VAIRRS Program Team
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