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Study Submissions

Do all submissions go thru the iMedRIS system? Yes, all submissions, except those with special circumstances, are submitted online through iMedRIS. New study and HUD applications and reporting forms for continuing studies are available in iMedRIS.

Investigators and study coordinators can view, access and revise consent documents and upload study documents directly into the study folder to attach to IRB submissions and reports. While most submissions are able to go through iMedRIS, there may be some with special circumstances that are not appropriate for routine submission through iMedRIS. For special circumstances, e.g., emergency use requests or if you have questions contact your local IRB.

Do I need to save my work?  
YES, you are encouraged to SAVE your work frequently. Unsaved work is not retained and will be lost. If you are inactive in the iMedRIS system it will time-out and automatically log you out. We strongly recommend that you save your work often.

Will iMedRIS guide me to the right forms for my study?

  • Yes, iMedRIS will guide you thru the form(s) needed to submit a new application and for reports on continuing studies.
  • For new study applications
  • Continuing studies    
    • Log into iMedRIS
    • On your homepage select the Research Assistant tab
    • Click on My Projects
    • Select a study and   Click to open
    • Select from the list of Protocol Items the type of form needed; e.g., Modification, DSMB, Internal Adverse Event, Enrollment Closure, etc.
  • Complete the form fields and route to the PI for signature
  • When the PI signs the submission the form automatically submits to the IRB
  • You can check to location of any submission by looking at Submissions History, Track Location 

How do I enter a new study application submission?

  • Log into iMedRIS
  • On your homepage select the IRB Assistant tab
  • Click on  Add a new Study
  • Use the SAVE and Continue to the Next Section tab on each page to proceed through the form(s)

Why can’t I add a new investigator, study staff member or contact?

  • The person you are attempting to add may not have an iMedRIS User account. Before you are able to add new investigators or staff members to your study a user account must be requested and created.

Why can’t I edit my application?

  • Once you have submitted an Application to the IRB the application and associated documents are locked down and become a part of the official study record and cannot be edited, without creating a revised application. To revise or edit the application, you can Retract the submission, or the IRB can return the application for corrections.

When does my study receive a study number?

  • All study application or submissions can be identified by two different numbers. iMedRIS system will automatically assign a 7-digit number to each new study application/submission.
  • iMedRIS system will automatically assign a 7-digit number to each new study application/submission. Study/IRB number is assigned when you submit a new study application to the IRB. The alpha prefix EVR, NHMC, SJHMC, SAC in the  Study/IRB number identifies the IRB of record, the year of initial review/approval and has a numeric placeholder for the study,
  • The Study/IRB number is assigned when you submit the study application to your IRB of record, EVR, NHMC, SJHMC, SAC etc. The alpha prefix indicates the IRB of record, the first two digits represent the year in which the study was initially reviewed or approved in iMedRIS. e.g., EVR 12-123 and the remaining digits are your study’s number, in sequence, with others studies submitted that year to the IRB.
  • The Reference # is assigned to every submission form created in iMedRIS and helps you to track each submission. The Reference # will remain constant for your submission and does not change during or after the review. The Reference# will help you to identify individual submissions, whether it’s the original submission, a submission response or a document in the study history that is linked.

What if I have a problem with the forms or using iMedRIS?

  • If you have problems with the forms or using iMedRIS click on Help links that are embedded in the study forms
  • Operating Procedures for specific help tips on reporting a problem.
  • Contact your local IRB staff

How do I find help in completing documents?

  • Help for completing documents can be found in HELP links that are embedded in the study forms. The links are located on the right side margins and visible throughout the study forms,
  • Dignity Health policies and forms are available in the My Assistant tab in Operating Procedures
  • Contact your local IRB staff

If you don't find the answers you're searching for, please call the East Valley Regional IRB at (480) 728-3582.