Axiom’s Mentor IRB software is a fully online protocol management system. The Mentor IRB software supports multiple IRBs and allows each to manage the review process from investigator submission to continuing reviews and adverse event reporting. Mentor’s IRB software is customizable. Your IRB doesn’t need adverse event reporting? No problem, the administrator can just turn it off.
Like all Mentor components, Mentor IRB is a fully hosted SaaS solution. We manage all backups, security (PCI Certified), data encryption and upgrades. Our software integrates with popular client identity management systems (LDAP, CAS, Shibboleth).
We guarantee 99.95% up-time.
- Info Page – The IRB chair or admin can create an info page for all investigators with instructions, and general information.
- Documents Page – A portion of the Mentor Document Management System where the IRB chair or admin can post general interest documents. For example, the IRB SOP’s, copies of the regulations, general policies, etc.
- My Protocols Page – A list of currently active protocols for each principal investigator. The PI can choose to list new (unapproved), active, terminated, and exempt protocols.
- Protocol Submission – A simple form that collects the important information about the protocol from the PI. PI’s can upload the protocol, consent form and any other documentation relevant to the IRB review process.
- Research Coordinator – PI’s who have research coordinators or secretarial support can designate individuals to manage their IRB protocols in Mentor.
- Continuing Review – Once a protocol is approved, a continuing review (annual report) record is automatically generated with a due date. The PI can submit the report and request continuation or terminate the protocol.
- Adverse Event Reporting – Each protocol supports an unlimited number of adverse events to be submitted by the PI.
- DSMB Reporting – Each protocol supports the submission of data safety monitoring board reports.
- Amendments – Each protocol supports the submission of amendments to the protocol. Amendments are filed as uploaded documents, including revised consent forms (if necessary).
- Department Chair Approval – The IRB can require department chair approval for submitted protocols. The department chair is notified of a new submission and has an interface to review protocols by their faculty and approve the submission to the IRB.
- Student PIs – The IRB can switch on student submission of protocols and can require a faculty/staff person as co-PI. The co-PI is notified automatically when they are selected onto a student protocol.
- Support for Multiple IRBs – Mentor will handle as many IRBs as your institution has, each with its own independent interface.
- Notifications – Upon submission of a protocol or any other element related to it by the PI, a notification email is sent to IRB administrators/members who can elect which specific notifications to receive.
- Canned Notifications – The IRB Chair or Administrator can create notification templates for all the standard communications between the IRB and the PI: approval, expedited approval, exempt certification, tabled, continuing review approval, new protocol, new continuing review, etc.
- Continuing Review Reminders – Mentor will automatically send a reminder email to the PI informing them of an impending continuing review due date. IRB Members can access the full protocol and all documentation and reports. IRB Chair & Administrator can access and modify all elements of the protocol as well as change the status of protocols (e.g., from new to approved).
- Forms – IRBs may have specific questions that they ask their PIs to answer. The IRB administrator can create custom multi-part forms and can add questions to the initial protocol submission form. Mentor forms use conditional logic so that you can require a specific form based on review level or options selected on various drop down menus on the initial submission for. You may also create custom forms to be completed by the faculty adviser/supervisor of student protocols, by each reviewer role and custom forms for continuing reviews.
- Assigned Reviewers – IRBs often assign specific members to review specific protocols in depth. Mentor allows the chair to define one or more reviewer roles and assign individual IRB members to review specific protocols. Reviewers have a special form to submit comments prior to the IRB meeting. If necessary, non-members of the IRB can be assigned as reviewers of specific protocols.
- Meeting Agenda and Minutes – Mentor will generate an agenda automatically based on the status and dates of submission of new protocols and reports received. Each agenda item has a Discussion Notes field for summarizing the discussion. Mentor then generates a separate minutes document from the agenda. The agenda includes meeting attendance and optional vote attendance, a meeting attendance polling function as well as fields for administrator notes one individual items and IRB Member notes as well.
- Notifications to PI – All email notifications sent from Mentor, whether automatically or by the chair/administrator are logged. Approval and revisions required notifications are printed to PDF and attached automatically to the protocol. Mentor has over 70 notification templates that support a wide variety of “merge” variables so that the templates are automatically populated with import protocol specific information (PI name, chair name, protocol ID, title, date of approval, due dates, etc.).
- Communications – A simple messaging service for PIs and members of the IRB to communicate about the protocol. Messages can be limited to just the IRB, or specific members of the IRB, or include the PI. Messages are archived and become part of the permanent record of the protocol.
- Tracking Status – Mentor has a customizable “tracking status” menu that allows the administrator to assign a status to each protocol based on where it is in the review process. The tracking status changes are logged with a time stamp and Mentor will generate a report for each protocol (or supplemental protocol report) showing the amount of time the protocol remained in each status. Great for improving efficiency and tracking where bottlenecks exist.