Mentor IRB - Sitero Technology - Clinical Trial

Mentor IRB

Sitero Mentor’s online IRB software saves you time and money with automated documentation and workflows. Mentor IRB is easily configured, intuitive and affordable.

Manage your Institutional Review Board with ease on our fully hosted SaaS solution

Sitero Mentor IRB – Next Generation IRB Software Platform

  • Info Page – Mentor IRB software enables the IRB chair or admin to create an info page for all investigators with instructions, and general information.
  • Documents Page – The Mentor IRB Document Management System can store all of your IRB’s important documents online without regard to file type or size. For instance, the IRB chair or admin can post general interest documents such as 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 can designate who have research coordinators or administrative 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.

  • Reportable Event Reporting – Each protocol supports an unlimited number of Reportable Events to be submitted by the PI.
  • DSMB Reporting – Each protocol supports the submission of data safety monitoring board reports.

  • Amendments – The Mentor IRB system supports the submission of amendments to the protocol. Amendments are filed as uploaded documents, including revised consent forms (if necessary).

  • Support for Multiple IRBs – Mentor IRB software 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.

  • Reviewer Assignments – 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.
  • 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.

Key Features for the IRB Administrator/Chair

  • Support for Multiple IRBs – Mentor IRB software 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.