IRB:提交您的协议

IRB Mentor is an interactive web application 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 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. 提交的路由 and the type of review it undergoes will be determined when it is screened by the IRB办公室.

Starting June 1st 2023 new study applications must be submitted via IRB Mentor. 新 study submissions will no longer be accepted via email after this date. 

IRB导师登录

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 请按以下连结登入: 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). 如果你 do not receive communication from us when expected, please check your preferred email 地址或垃圾邮件文件夹.

如果你 are an employee of the 菠菜网lol正规平台 研究基金会 only, please 联络我们的办事处 登录链接.

初次提交的基本步骤

1. 在Mentor中创建协议 初次提交使用指引[pdf].
   
   
2. Fill out the application sections and attach any files where prompted, following our 档案要求使用者指引[pdf].
   
   
3. Electronically sign by clicking the button next to your name on the protocol information 页面. This will deliver the protocol to the IRB办公室 if you are a faculty or staff 成员. 如果你 are a student, this will deliver the protocol to your faculty supervisor, 谁应该跟随我们 教务主任使用指引[pdf]. Do not forget this step – your submission will not be delivered to the IRB if you 还没有在提交的文件上签名! 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.

导航IRB Mentor的用户指南

以下用户指南是必须阅读的. 请花15-20分钟阅读 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.

首次提交意见书[pdf]
Outlines steps and guidance for creating a new protocol, submitting requested revisions, approval durations, submitting study status check-ins.

院系主管[pdf]
Provides information on how to navigate your review and acceptance of student submissions 内部IRB导师.

档案要求[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 已批准的协议).

Post-Approval Reporting: Modifications, Incident Reports, Deviations [pdf]
Provides information on how to navigate submission of modification requests, reporting of incidents and unanticipated problems, reporting of study deviations/protocol 违反.

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批准他们的研究. 也请参考我们的 合作和外部研究页面 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 流程在IRB导师.

IRB成员

访问我们的 审稿人培训页面 for a list of steps and training requirements for IRB 成员s, including a reviewer user guide for navigating your review of protocols in IRB Mentor.

IRB导师智能表格申请

For a PDF preview of the smart form application in IRB Mentor, visit our 表格及文件页.

管理Pre-IRB导师提交

While new submissions will not be accepted via email after June 1st 2023, the 菠菜网lol正规平台 IRB将继续接受 修改请求[docx], 状态报告[pdf], 事故报告[docx] 邮件地址:irb@jkchealthtech.com for IRB protocols approved prior to the implementation 直到2024年4月1日. After April 1, 2024, you must submit a new protocol via the IRB Mentor system if you wish to modify a previously approved pre-IRB Mentor study. 我们不会添加pre-Mentor 系统协议.

If no modifications are anticipated, investigators may continue to submit status reports for their pre-IRB Mentor approved studies to irb@jkchealthtech.com. Pre-IRB导师研究 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 three years after an investigator communicates that a study is complete on their status 报告(以先到者为准). 

要访问我们的预irb导师表格，请访问我们的 表格及文件页.