iRIS Online Application System: Info and FAQs

Login into iRIS

What is iRIS?

iRIS (formerly known as iMedRIS) is the online application system you will use to submit your new study and all subsequent IRB submissions. The Human Gamete, Embryo, and Stem Cell Research Committee (GESCR) also utilizes iRIS.

iRIS enables online tracking, review, post-approval compliance activities and data management. The system also functions as a document repository, providing you with easy access to study records and documents. You can use iRIS anywhere you have internet access, connecting research partners around the world. Training is available.

Interactive TutorialsIn October 2018 we created a suite of interactive online tutorials for working in iRIS. Go to the iRIS Help website (MyAccess login required) to take these tutorials.

Accessing iRIS

See the iRIS Account page for detailed information on obtaining an account.

iRIS is accessible via MyAccess. Click the "IRB - iRIS" link. The use of is VPN no longer required or recommended for off-campus access.

If you need access to particular studies within iRIS, review the next FAQ, "How can I be added to a study?"

If you are Key Study Personnel, a current member of the study team must submit a modification to request that you be added to the study.

If you are research support staff or a study contact who is not Key Study Personnel, you are not required to submit a modification to be added to the study.

The IRB may grant special departmental access to department MSOs, department Research Finance Administrators or other individuals who can justify needing this type of access.

Follow these instructions. After you receive this access, you will have read-only access to all studies that are being done in your department(s). You will be able to access copies of approval letters via Submission History, view the IRB Application to see which funding sources and personnel are on the study, or print or save copies of the IRB Application, consent forms, etc.

The current version of iRIS is compatible with all browsers. Turn off the web browser’s pop-up blocker for the iRIS site.

  • If you receive the pop-up error message 'blockUI requires jQuery v.1.2.3 or later! You are using 1.11.1,' clear the cache in your browser
  • Consult with your Desktop Support analyst regarding which version of browser you should use based on the applications you access. 

Do Sponsors have access to iRIS?

No, Sponsors are not granted access to iRIS and should request documents through the study team.

System Info

Both MyAccess and iRIS will automatically log you out if you are inactive in the system. As such, we recommend that you save your work regularly.

Interactive TutorialsGo to the  iRIS Help website (MyAccess login required) to take these tutorials. 


Quick Guides – These PDF quick guides that contain step-by-step instructions and screenshots. They are available on the iRIS Help website or within iRIS by clicking on the Help button in the right-hand corner.

Submission Instructions – The Submissions section of our website has instructions and guidance on entering new studies and other submissions in iRIS. 

Application Help Links – If you get stuck answering a question in iRIS, hover over the help bubble next to the question and then click on the link that appears for Instructions and/or Guidance.

iRIS Application Outlines – The outlines include all potential sections you may need to complete and can be used as guides. They are available in the Help section in iRIS.

Training Classes –The IRB offers several in-person training sessions. Registration is required. 

Contact Us – You can contact our office at (415)476-1814 or [email protected].

Here are just a few of the benefits that the iRIS system offers to investigators and their support staff:

Faster review process and communication of status – Electronic submission will reduce processing time and speed up the time to approval. PIs and study contacts will receive approval letters by email immediately after they are prepared.

Study information at your fingertips – Where you have Internet access, you have access to your protocol information.

Improved document management – The system identifies which documents are currently approved, helping you use the correct versions.

Intuitive application – The IRB Application will branch out based on how you answer key questions, so you won't have to figure out which supplements to submit.

Documentation of submission for sponsors – You will have a record of each document that you submit.

Easier access to IRB approval records – Study approval records will be accessible to PIs, study staff, and key departmental administrators.

Environmentally friendly – Prior to the implementation of iRIS, the IRB received about 5 million pieces of paper each year. The electronic system has helped us eliminate this waste and supports UCSF's efforts to incorporate environmentally-friendly practices across campus.

iRIS has been implemented as a Closed System at UCSF, consistent with 21 CFR Part 11. Every user of the system must be individually authenticated and specifically authorized to gain access to the system. Additional levels of control and authorization are required before users can carry our specific functions within the system (e.g., to submit, review and/or approve research).

Users must log into the system through a secure portal which the University monitors, and users are required to use both a unique ID and a password to gain access the system.  Users are required to protect and keep confidential their IDs and passwords and follow all University information security policies. Users are responsible for the actions, certifications and determinations they make while logged into the system. Actions within the system are recorded and time-stamped. Study and system records are available for review in both printed and electronic format.

Entering and Submitting Study Submissions

Information on entering new studies is provided in the New Study page. The online IRB Application form uses branching technology, and certain sections of the form will automatically appear after you answer key questions. You do not need to navigate through sections of the IRB Application that do not apply to your type of study.

It may take as little as 30 minutes for a chart review study to several hours or even several days for a complex study. Before you enter your study, review our guidance on submitting new studies. Also, review the factors that may affect the time it takes to enter a study to learn how you can prepare to submit your study: 

How complex is your study? – The iRIS applications build and branch based on how you answer key questions, so the applications for complex studies usually have more sections. 

Are you prepared to answer all of the questions in the IRB and/or GESCR Applications? – Look over the iRIS application outlines to see which questions you may be asked to answer. Contact members of your research team or the study sponsor for help. If your study is being funded through UCSF, be sure to ask your Research Services Analyst (RSA) for information about the funding source, including the RAS proposal or award number.

Do you have access to all of the supporting documents you need to attach? – Go over the Initial Submission Checklist to determine what attachments you need to submit.

Is the PI available to sign off on the study? – The PI must electronically sign off on the initial review, so factor in the PI’s availability if you are not the PI of the study.

Yes, use the iRIS application outlines as guides to see which questions you may need to answer in the electronic application(s). The outlines are available in the Help section in iRIS. Some sections of the applications are only required if your research has certain characteristics.

Once your application is submitted to the IRB, it is locked and becomes part of the official study record. You will need to add a revision in order to edit it.

You also may be unable to edit and/or save changes if you are looking at the application in “Entire View.” Switch to “Section View” in order to edit.

Most likely, you have not lost your work. Instead, you have either: a) changed an answer that affects the way the form branches or b) finished the application and entered the Initial Review Submission Packet. 

Branching Change: Changing some answers will affect the way the IRB Application branches. Sometimes section links will disappear from the left-hand menu of the form. You have not lost any work – data you previously entered is still there, but new sections may have been added to the form. You must click the "Save and Continue to the Next Section" button through each page to rebuild the form before you can submit it. Also be sure to answer any new questions. 

Entering the Initial Review Submission Packet: The last section in the IRB Application is labeled “End of Study Application.” Unless you need to complete the GESCR Application, you will automatically enter the Initial Review Submission Packet after you click “Save and Continue to the Next Section” on this page.

The Initial Review Submission Packet is a separate form in which you will add a lay study summary, list special processing instructions, and attach consent forms or other study documents.  The application you just completed also will be automatically attached here. The Initial Review Submission Packet bundles all of the components of the submission together, kind of like stapling a paper packet. 

If you need to get back into the IRB Application to edit or check your work, you can get there by one of two ways:

Option #1: Section 2.0 of the Initial Review Submission Packet

  • The IRB Application is attached in section 2.0 of the Initial Review Submission Packet, so you can get to by following these steps: 
  • Answer the questions in section 1.0 of the Initial Review Submission Packet.
  • Click “Save and Continue” in section 1.0.
  • Click the Edit/View icon next to the application. This will take them back into the application form. 

Option #2: Study Mgmt Link in Navigation

  • Click on the “study mgmt.” link in the Navigation list (beneath your account name and department).
  • You will then see the study dashboard. The link to the application is on the left-hand side of this page. Click on the link and then click the "Edit/View" button next to the correct version.

If neither of these two scenarios match your situation, contact the IRB office at (415) 476-1814.

When you click on the My Studies button from your home page, you will see a list of your studies. Next to each study, you will see a Copy button. This button will copy the Application for that study. It will not copy the attachments.

You can copy a study that is incomplete and in draft status or a study that has been submitted. Some users have created a IRB Application template that they never submit, and they instead copy that template each time they begin to submit a new, similar study.

Note: If you copy a study, the copy will not be assigned a study number until you submit it. Please remember to update the study title in section 1 of the Application.

Anyone can fill out the study application, but the PI must sign off on and submit a new study. The PI must also sign off on and submit the Continuing Review Form. All other study submissions can be submitted by investigators, research support staff or study contacts who are listed in section 3 of the IRB Application. 

Important Note: Only individuals listed in section 3 of the IRB Application will have access to the study (via My Studies) after it is submitted. If you are not Key Study Personnel but need access to the study, be sure to add yourself as a study contact.

Study contacts are copied on all important email notifications that the PI receives, including requests for submission corrections, approval letters and continuing review reminders. You can add as many study contacts as you’d like in section 3 of the IRB Application. 

The iRIS system sends correspondence pertaining to submissions and reminder notices for Continuing Review to the PI and Study Contacts. If your study has a Co-Principal Investigator or a supervising or mentoring Investigator (for Resident, Fellow, and Post-Doc PIs), please add them as Study Contacts to ensure they receive study-related correspondence.”

Study Status and Tracking

Submission tracking is incredibly easy in the iRIS system.

  • Go to the My Studies section and open the study.
  • Click on the "Submission History" link
  • Locate the submission you want to track, and click the Track Location icon.

You will be able to see which IRB panel received the submission and which IRB analyst has been assigned to process the submission. If the submission has been assigned for review, you also will be able to see that information. You can contact the assigned analyst for more information.

In the workflow tracking, you should see a note that says, "IRB Committee XX Panel received the submission." If you do not see this note, the IRB may not have received the study. Contact us at (415) 476-1814.

The overall study has a status in iRIS. Here are what these statuses mean and some important notes about the statuses. You can also check the Submission History if you need more detail about where the study is at in the review process.

Important Notes About Study Statuses

  • The study status automatically updates from "Draft" to "Pending – Submitted for Initial Review" once you submit the study to the IRB. The status will also automatically change to "Expired" once the expiration date is reached the the study has not been renewed. The IRB manually updates all other statuses according to the type of study and where it is in the review process.
  • Only studies with a "Draft" status can be deleted by the study team. If you need to delete a study that has already been submitted, contact the assigned IRB analyst and request for the study to be withdrawn.
  • If the study status is green, the study is Active and can be conducted as described in the application. The only exception is for pending modifications — the IRB must approve the modification before the change can implemented. Pending modifications do not change the overall study status.

Study Statuses: 


The study has not been submitted and is still in draft mode. Follow the final step in the "Creating a New Protocol" quick guide if you thought you submitted the study, but the study is still in Draft status. This quick guide is accessible by clicking on the Help icon in iRIS.

Pending - Submitted for Initial Review

The study has been submitted. Check the Submission History for more information on the study status/workflow tracking.


The study is active and approved by the IRB. (Note that this status is being phased out and will be replaced by one of the following Active statuses at the time of your next submission to the IRB.)


The exempt study is active and approved by the IRB.

Active - Expedited

The expedited study is active and approved by the IRB.

Active - Full Board

The full board study is active and approved by the IRB.

UC MOU - Relying

The study is active. The study is relying on another UC IRB for review.

Active - Closed to Accrual

The study is active and approved by the IRB. The study is closed to accrual of new subjects.

Active - Data Analysis Only

The study is active and approved by the IRB. The approval is limited to data analysis activities.

UC BRAID - Reviewing

The study is active and approved by the IRB. This study is part of a multicenter clinical trial that is conducted at multiple UC sites. This application serves as a primary point of review for other UC sites participating in this clinical trial. For more information visit the UC BRAID website.

UC BRAID - Relying on Other UC

The study is active. This study is a multicenter clinical trial and is relying on the review of another UC site participating in the clinical trial. For more information visit the UC BRAID website.

CIRB Reviewed

The study is active. The study is relying on the NCI CIRB for review.

Returned for Pre-review Changes

The IRB has returned the study for correction during the pre-review screening process. Look for the Submission Correction task on your home screen.

Returned by Committee

The IRB has returned the study for revisions or clarifications after formal review. Look for the Submission Correction task on your home screen.


The study has expired.


The study has been closed.


The study has been withdrawn by the IRB.


The study has been suspended. You will receive more information from the IRB about the suspension.

Active: Hold on Accrual

The IRB has put a hold on accrual. You will receive more information from the IRB about the hold.

Not Human Subjects Research​

The IRB will not review the study because the study does not qualify as human subjects research.

The iRIS system automatically assigns a 7-digit number to your study. The first two digits represent the year in which you first add your study in iRIS. The study retains this 7-digit number for its life.

After you submit an initial review or post-approval form (e.g. the Continuing Review Form), that submission is assigned a unique reference number. If the IRB sends the submission back to you for corrections, the response you submit back to the IRB via the Review Response Submission Form will be assigned the same reference number as the original submission. This number will help you figure out which submissions (original or responses) are linked.

You can find the reference number in the Submission History. You also can open the study via My Studies, click on the name of the form you submitted (e.g. Initial Review Submission Packet or Modification Form) and see the reference number there.

Funding Questions

Consent Documents, Other Study Documents and Approval Letters

Managing Your iRIS Submission


Last updated: September 27, 2023