IRB: Submit Your Protocol
IRB Mentor is an interactive web application that uses smart forms. You do not need to identify whether your submission qualifies for exemption [pdf], expedited review, or full review. 菠菜网lol正规平台 does not use different applications for different review types. Instead, different sections and questions are made visible based on how you respond to questions as you move along in the application. The routing of your submission and the type of review it undergoes will be determined when it is screened by the IRB office.
IRB Mentor Login
LOGIN: 菠菜网lol正规平台 students and employees have automatic access to IRB Mentor via 菠菜网lol正规平台 single
sign-on at the following link: http://www.axiommentor.com/login/shibLogin.cfm?i=sjsu
IMPORTANT NOTE: The Mentor system is set up to send notifications to the email address
that you identified as your preferred email address in Peoplesoft (my菠菜网lol正规平台). If you
do not receive communication from us when expected, please check your preferred email
address or spam folder.
If you are an employee of the 菠菜网lol正规平台 Research Foundation only, please contact our office for a login link.
Basic Steps for an Initial Submission
- Create the protocol in Mentor following our User Guide for Initial Submissions [pdf]. Make sure that all required documents [pdf] are ready to be uploaded.
- Fill out the application sections and attach any files where prompted, following our
User Guide for File Requirements [pdf].
- Electronically sign by clicking the button next to or under your name on the protocol information page. This will deliver the protocol to the IRB office if you are a faculty or staff member. If you are a student, this will deliver the protocol to your faculty supervisor, who should follow our User Guide for Faculty Supervisors [pdf]. Do not forget this step – your submission will not be delivered to the IRB if you have not signed your submission! Faculty supervisors should receive an email confirmation both when their student has signed the submission and it is ready for the supervisor to review/accept as well as upon delivery to the IRB when the faculty supervisor accepts the submission.
User Guides for Navigating IRB Mentor
The following user guides are required reading. Please take 15-20 minutes to read the user guides relevant to your submission type – reading this information prior to accessing the IRB Mentor system will save you time in the long run.
Initial Submission [pdf]
Outlines steps and guidance for creating a new protocol, submitting requested revisions,
approval durations, and submitting study status check-ins.
Faculty Supervisors [pdf]
Provides information on how to navigate your review and acceptance of student submissions
within IRB Mentor.
File Requirements [pdf]
Outlines required naming and formatting conventions for files uploaded to IRB Mentor
as well as how to use Mentor’s organization and management features for files.
Post-Approval Study Status Check-ins or Continuing Reviews [pdf]
Provides information on approval durations and instructions for submitting either
a study status check-in or a continuing review request (depending on the review type
of the approved protocol).
Post-Approval Reporting: Modifications, Incident Reports, Deviations [pdf]
Provides information on how to navigate submission of modification requests, reporting
of incidents and unanticipated problems, and reporting of study deviations/protocol
violations.
External IRB Approval Registration and Reliance Agreements [pdf]
Provides navigation instructions for 菠菜网lol正规平台 investigators who intend to rely on an external
IRB approval for their research. Please also refer to our Collaborative and External Studies page for preliminary information so that you understand what is required to establish
a reliance agreement between 菠菜网lol正规平台 and the external reviewing IRB before initiating
the process in IRB mentor.
IRB Members
Visit our reviewer training page for a list of steps and training requirements for IRB members, including a reviewer
user guide for navigating your review of protocols in IRB Mentor.
IRB Mentor Smart Form Application
For a PDF preview of the smart form application in IRB Mentor, visit our forms and documents page.
Managing Pre-IRB Mentor Submissions
We are no longer accepting new submissions or modification requests for pre-Mentor submissions via email, as the one year grace period since the implementation of Mentor has expired. Investigators who wish to make revisions to pre-Mentor studies must submit a new protocol via the Mentor system with their modifications incorporated into the Mentor application. We will not add pre-Mentor studies and forms to the system. You will not find your pre-Mentor protocol in Mentor when you log in. Please submit a new protocol if you wish to make a modification. You can include the pre-Mentor tracking number in the Message to the IRB text field when creating your protocol so that we can ensure consistency of review. Please also be sure to indicate in the Message to the IRB text field whether you are still recruiting subjects, obtaining consent, and collecting data to ensure that we review the submission appropriately.
Status Reports for Pre-Mentor Studies
If no modifications are anticipated, investigators may continue to submit status reports [pdf] and incident reports [docx] for their pre-IRB Mentor approved studies to irb@big5vn.com. Pre-IRB Mentor studies will be maintained outside of the system, so long as no modifications are requested, for three years after the last status report was received by the IRB office or when an investigator communicates that a study is complete on their status report (whichever comes first).
