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Committee Management Software- V A Innovation and Research Review System (VAIRRS)

VAIRRS is an enterprise-wide committee management software designed to streamline the research review process in the Department of Veterans Affairs. It provides a centralized platform for managing research committee activities and facilitates efficient communication and decision-making.

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Committee Management Software- V A Innovation and Research Review System (VAIRRS)

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  1. Committee Management Software- VA Innovation and Research Review System(VAIRRS) Angela Foster, Program Analyst, ORPP&E, ORD Molly Klote, MD, CIP, Director, ORPP&E, ORD August 2019

  2. Introduction • VHA needs an overarching research review and management software (post award software) • ORD made the decision to pursue a commercially available software platform in June 2019 • ORPP&E began efforts to sole-source an enterprise-wide committee management solution • Committee management solution formally branded VA Innovation and Research Review System (VAIRRS)

  3. History • Prior software development • MIRB • RCMS • 31 sites with contracted software platforms • 29 VAMCs relying on affiliate platform • VA Central IRB (CIRB) – MS Access/SQL Server/ SharePoint • Others (paper based, excel, etc…)

  4. Status of Current Platforms • MIRB and other commercial platforms- contracts negotiated and managed locally by site • RCMS – Six month Strategic Technology Alignment Team (STAT) waiver granted in July 2019. Allows for continued use of unsupported systems. https://vaww.ea.oit.va.gov/stat-waivers/

  5. Where are we now? Post contract award Tier 1 VAIRRS package is currently under review by contracting. Tier 2 ATO is already being worked for systems currently under operation Tier 3 Anticipated Aug 2019 Dec 2019 Aug 2020 Dec 2020-2023 *ATO = Authority to Operate

  6. Planned Migration Cycles Planned migration cycles are dependent on contract award • Tier 2 • Sites with no system/paper • Current sites with contracts expiring one year – 18 months post-award • Tier 3 • Sites that use an affiliate committee for research review and approval – will maintain the ability to continue to rely • Current sites with contracts expiring after 18 months post-award • Tier 1 • Sites using MIRB, RCMS, and sites with data transfer to RAMS • Current sites with contracts expiring one year post-award or sooner

  7. Data Migration • ORPP&E is exploring how to export data effectively and efficiently from MIRB, RAMS, and RCMS. • MIRB data is accessible via Export utility or direct access to tables. • ORPP&E will coordinate a community of knowledge to share data migration successes and lessons learned.

  8. Short Term Bridge • Use of the CIRB system available to MIRB and RCMS users and sites with no electronic system • Developed by CIRB staff • Can be cloned for your site • Robust reporting • MS Access front-end/SQL Server/SharePoint • Not 21 CFR 11 compliant – need filing system for FDA regulated studies • If interested, Angela.foster@va.gov (Angie)

  9. Plan B/What If? Scenario • If sole source is NOT approved: • Will issue a Request For Proposals (RFP) • Will delay contracting by 6 months We will have a commercial enterprise solution

  10. Questions? Dr Molly Klote, MD Director, Office of Research Protections, Policy, and Education Office of Research and Development 202-443-5605 (o) Mary.klote@va.gov Angela Foster Program Analyst, Office of Research Protections, Policy, and Education Office of Research and Development 202-443-5822 (o) Angela.foster@va.gov

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