IRB: Submit Your Protocol
IRB Mentor is an interactive web 应用程序 that uses smart forms. 你不需要 to identify whether your submission qualifies for 豁免(pdf), 加快审查，或全面审阅. 菠菜网lol正规平台 does 不 use different 应用程序s for different review types. Instead, different sections 和 questions are made visible based on how you respond to questions as you move along in the 应用程序. The routing of your submission 和 the type of review it undergoes will be determined when it is screened by the IRB办公室.
IRB导师登录
LOGIN: 菠菜网lol正规平台 students 和 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 不ifications to the email address
that you identified as your preferred email address in Peoplesoft (my菠菜网lol正规平台). 如果你
do 不 receive communication from us when expected, please check your preferred email
address or spam folder.
如果你 are an employee of the 菠菜网lol正规平台 Research Foundation only, please 联络我们的办事处 登录链接.
Basic Steps for an Initial Submission
- Create the protocol in Mentor following our User Guide for Initial Submissions [pdf]. 确保 all required documents [pdf] are ready to be uploaded.
- Fill out the 应用程序 sections 和 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 信息页面. This will deliver the protocol to the IRB办公室 if you are a faculty 或者工作人员. 如果你 are a student, this will deliver the protocol to your faculty supervisor, who should follow our User Guide for 教师 Supervisors [pdf]. Do 不 forget this step – your submission will 不 be delivered to the IRB if you have 不 signed your submission! 教师 supervisors should receive an email confirmation both when their student has signed the submission 和 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 和 guidance for creating a 新 protocol, submitting requested revisions,
approval durations, 和 submitting study status check-ins.
教师 Supervisors [pdf]
Provides information on how to navigate your review 和 acceptance of student submissions
内部IRB导师.
File Requirements [pdf]
Outlines required naming 和 formatting conventions for files uploaded to IRB Mentor
as well as how to use Mentor’s organization 和 management features for files.
Post-Approval Study Status Check-ins or Continuing Reviews [pdf]
Provides information on approval durations 和 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 和 unanticipated problems, 和 reporting of study deviations/protocol
违反.
External IRB Approval Registration 和 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 和 External Studies page for preliminary information so that you underst和 what is required to establish
a reliance agreement between 菠菜网lol正规平台 和 the external reviewing IRB before initiating
the process in IRB mentor.
IRB成员
访问我们的 reviewer training page for a list of steps 和 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 应用程序 in IRB Mentor, visit our forms 和 documents page.
Managing Pre-IRB Mentor Submissions
We are no longer accepting 新 submissions or modification requests for pre-Mentor submissions via email, as the 一个 year grace period since the implementation of Mentor 已经过期. Investigators who wish to make revisions to pre-Mentor studies must submit a 新 protocol via the Mentor system with their modifications incorporated into the Mentor 应用程序. 我们将 不 add pre-Mentor studies 和 forms to the system. You will 不 find your pre-Mentor protocol in Mentor when you log in. Please submit a 新 protocol if you wish to make 一个修改. 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, 和 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] 和 incident reports [docx] for their pre-IRB Mentor approved studies to irb@thehomecosmos.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办公室 or when an investigator communicates that a study is complete on their status report (whichever 是第一位).
