{"id":"FR2100757165","name":"IRBNet on GovCloud","provider":"Research Dataware LLC","providerSlug":"research-dataware-llc","status":"FedRAMP Authorized","impact":"Moderate","authType":"Agency","authDate":"2023-03-31","serviceModel":["SaaS"],"deployment":"Government Community Cloud","businessFunctions":["Collaboration","Communication","Research"],"assessor":"Lunarline, Inc.","assessorId":"137004","smallBusiness":false,"website":"https://gov.irbnet.org","description":"IRBNet's powerful suite of web-based, Software as a Service (SaaS) research compliance solutions provide electronic submission, collaboration and workflow tools that currently serve thousands of research institutions, compliance boards and sponsors, and hundreds of thousands of users, across IRBNet's National Research Network (commercial) and IRBNet on GovCloud (government).\nIRBNet research compliance solutions support institutions of any size, and currently serve hospitals and hospital networks, universities and academic research institutions, and federal and state agencies. IRBNet’s secure suite of tools is accessible anywhere, anytime, supporting real-time collaboration between investigators and institutions anywhere in the world, helping to streamline compliance workflow, reduce review and approval cycle times, reduce errors and non-compliance, increase staff efficiency, and improve audit trails and record keeping.  IRBNet's tools are fully integrated and configurable, and support all institutional compliance offices, investigators and board members, including:\n- Institutional Review Boards (IRB)\n- Institutional Biosafety Committees (IBC)\n- Institutional Animal Care and Use Committees (IACUC)\n- Research & Development Committees\n- Radiation Safety Committees\n- Scientific Review Committees\n- Conflict of Interest (COI) and other specialty committees\n\nIRBNet provides the following core features to support local Agency mission needs and critical business functions, supporting compliance boards and researchers throughout the entire lifecycle of the research review and compliance process:\n- Project assembly, documentation and team collaboration\n- Electronic submissions\n- Routing, tracking and alerting tools for committee member review\n- Tracking of committee member comments and pre-reviews prior to meetings\n- Cross-institutional collaboration and communication tools\n- Custom Form Wizards to improve guidance and document quality (application forms, etc.)\n- Tracking of researcher and committee training and credentials\n- Multi-Site studies\n- Instant notification of study approval and other key events\n- Automated continuing review alerts\n- Quality control and pre-review tools\n- Agenda and Minutes Builders\n- Personalized Approval Letter and Correspondence Wizards\n- Document version control and history\n- Multi-board workflow management\n- Audit and oversight functions\n\nIRBNet also provides the following optional integration features to meet Agency mission needs:\n- IRBNet provides an optional connection to the WCG IRB for commercial IRB review services.  This service allows Agencies to seamlessly send research studies for commercial IRB approval, and receive back approval documentation such as Approval Letters, while maintaining oversight of the complete research portfolio (both internal and external).\n- IRBNet provides an optional connection to external training sources, such as Agency training systems or the national CITI program, to pull training information for researchers and committee members so that this information is readily available during compliance and review processes.\n- IRBNet provides an optional Single Sign-On federated authentication capability for Agency authentication frameworks such as PIV/CAC, to provide seamless access to Agency users.\n\nIRBNet on GovCloud is the Government Community Cloud offering of the IRBNet SaaS.  IRBNet on GovCloud is hosted in multiple availability zones within the Amazon Web Services (AWS) FedRAMP-authorized GovCloud Infrastructure as a Service / Platform as a Service (IaaS/PaaS).  All AWS GovCloud data centers are within the Continental United States (CONUS).\n\nIRBNet on GovCloud is managed by Research Dataware LLC., an operating unit of WCG Clinical, Inc. (WCG). WCG is the world’s leading provider of solutions that measurably improve the quality and efficiency of clinical research. ","logo":"https://www.fedramp.gov/assets/img/logos/CSP_logos/IRBNet%20Logo.png","inMarketplace":true,"agencies":["22-036"],"reuseCount":0,"leverages":["F1603047866"],"leveragedBy":[],"timeline":[{"date":"2020-10-06","to":"Agency Authorization In Process","certType":"Rev5"},{"date":"2021-10-07","to":"FedRAMP In Process","certType":"Rev5"},{"date":"2023-03-31","to":"FedRAMP Certified","certType":"Rev5"}],"cr26":{"type":"Rev5","ocrOverdue":false,"valid":true,"findings":[{"level":"warning","message":"no UEI number; include it if you have one","rule":"CDS-CSO-PUB"},{"level":"warning","message":"no business category listed","rule":"CDS-CSO-PUB"},{"level":"warning","message":"no trust center link; CR26 requires one with access instructions","rule":"CDS-CSO-UTC"},{"level":"warning","message":"no link to secure configuration guidance","rule":"SCG-CSO-RSC"},{"level":"warning","message":"no next Ongoing Certification Report date","rule":"CDS-CSO-PUB"},{"level":"warning","message":"no service list; CR26 requires the services in scope","rule":"CDS-CSO-SVC"},{"level":"warning","message":"no documentation overview (repositories) listed","rule":"CDS-CSO-PUB"}],"assessor":"Lunarline, Inc."},"sponsor":"22-036","trustCenterCheck":null}