Institutional Review Board (IRB) Protocol Management

IRB Management Software

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The Mentor Institutional Review Board Protocol Management (IRB) system is a fully online protocol management system for Institutional Review Boards. Mentor supports multiple IRBs and allows each IRB to manage the review process from investigator submission to continuing reviews and adverse event reporting. Mentor IRB is customizable. Your IRB doesn’t need adverse event reporting? No problem, the IRB administrator can just turn it off.

Key Features for the PI:

  • IRB Info Page – The IRB chair or admin can create an info page for all investigators with instructions, and general information.
  • IRB 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.

Key Features for the IRB Management Software:

  • Support for Multiple IRBs – Mentor will handle as many IRBs as your institution has, each with its own independent interface.
  • Notifications to IRB – Upon submission of a protocol or any other element related to it by the PI, a notification email is sent to IRB 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).
  • Multiple Reviewer Roles – The IRB can define reviewer roles (e.g., primary reviewer, medical reviewer, etc.) and then assign IRB members to these roles on specific protocols.
  • IRB Forms – IRBs may have specific questions that they ask their PIs to answer. The IRB system uses the Mentor Survey engine to allow the IRB to create a survey that each PI must complete on submission of a new protocol. The survey allows the IRB to ask for additional data not included on the protocol submission form, or it may be used as a decision tree to confirm exemption, expedited review or other protocol parameters. The IRB can in same way create checklists for IRB Reviewers to complete. Each reviewer role can have its own checklist.
  • Designation of Protocol Reviewers – IRBs often assign specific members to review specific protocols in depth. Mentor allows the chair to define one or more reviewer types 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.
  • Notifications to PI – Email notifications from the IRB chair or administrator are automatically saved as PDF files and attached to the protocol record.
  • 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.

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IRB Management Software