McLaren Health Care
iRIS

IRB Electronic Submission

We are pleased to announce the launch (go-live) of the new IRB software iRIS on December 30th, 2020!

Access iRIS at: https://mclaren.imedris.net/

When you log into iRIS for the first time, there may be a delay before you can fully use iRIS. After you log in for the first time, the System Administrator will have to manually set your role and department.

All technical questions and assistance will be handled through Donna Mott, Clinical Research Informatics Manager. We anticipate working through some technical problems as the iRIS system is launched, and we thank you for your patience. You may email your technical questions to the address below:

Donna.Mott@mclaren.org

iRIS is now available for you to access and submit all the following applications:
  • Request for Human Subject Determination
  • Confirmation of Scientific or Scholarly Review for Validity
  • Emergency Use of Test Article
  • Request for Use of External IRB
  • New Study Applications for exempt, expedited, or full-board IRB review
  • New HUD Application
  • Expanded Access (Compassionate Use) Application
  • Continuing Review or Annual Status Report
  • Modification Report
  • Unanticipated Problem Report
  • Protocol Violation / Exception Report
  • Final Report

Important Announcement Regarding Modifications and Continuing Reviews!

  • Data from legacy studies (studies IRB-approved in old IRB software system) from eProtocol have not yet been migrated over to iRIS. IRB-approved study information will be available in iRIS in the format of a “study shell.”
  • The “study shell” will contain the Protocol ID, study title, PI name, department, and study personnel. All legacy studies historical data will be migrated in approximately 8 weeks in the form of PDFs. This means all prior applications, amendments, continuing reviews, attachments will be brought over for each individual study as PDFs.
  • In the meantime, if you need a copy of your last version of your IRB-approved application or any other legacy document, please contact hrpp@mclaren.org to request a PDF copy of a previous submission. Enter “Request eProtocol PDF” in the subject line. In the body of your email, enter:

        - the study IRB No., study title, PI name, type and date or date range of the document you are requesting.
Although you will not have legacy data immediately available, the study shell will allow you to submit a continuing review / annual status report, modification, unanticipated problem report, protocol violation / exception report and final report.

When completing a modification or continuing review application follow the instructions below:


For Legacy Studies (studies IRB-approved in old IRB software system)

In the application, when asked to select all the proposed changes you are instructed: “If the changes impact information in the original application, you must also go to the appropriate section(s) and enter your updates.”


Until further notice, you will not have the ability to make changes to the original application.

If you need a copy of your last version of your IRB-approved application or any other legacy documents, please contact hrpp@mclaren.org. Include your protocol number, PI name, and document you are requesting.


If your study was approved by the IRB in the iRIS system

You will follow the instruction: “If the changes impact information in the original application, you must also go the appropriate section(s) and enter your updates.”

When the time comes for data migration with PDFs you will receive new directions on making changes to an application.

 

BASIC IRIS INSTRUCTION

Study Submission in iRIS

Existing McLaren users, please use your McLaren credentials to log in to iRIS (user ID and password). On the Study Assistant Workspace home screen, click the button on the left of the screen to Create a New Study. Choose your New Study Application from the list that appears. Complete the Study Application. The Study Application is a smart form and questions will appear based on the answers you choose (branching). When you have completed the application, you will be directed to the Initial Review Submission Packet screen. Attach the appropriate documents in this panel:

Informed Consent

  • Informed Consent
  • Any other handouts or material that will be given to participants to assist with the consent process

Study Documents (for example)

  • Drug/Device Information
  • Explanatory Diagram (Sequence of Events)
  • FDA Letter(s)
  • HIPAA Authorization or Waiver Form
  • Letter(s) of Agreement/Cooperation
  • PI Affirmation
  • Project Impact Statement
  • Protocol
  • Questionnaires/Surveys
  • Recruitment Material (e.g. flyers, email text, verbal scripts)
  • Other Supplemental Information

When you have attached all the documents, click Signoff and Submit or Notify PI to Signoff. If the submission requires additional routing for approval prior to submission, you will be directed to a panel that lists names of key study personnel. Check the boxes next to the names of all the co-investigators so that the application packet is routed to them for electronic signature and COI disclosure. When everyone has signed off, the application will be sent to the MHC IRB queue. You may check the status of the application at any time by checking Workflow Tracking.

iRIS Training Video for Researchers: Basic Navigation of Commonly Used Areas and Creating a New Study (with Voiceover)

View/Download PDF:
Determination of Human Subject Research and Setting up Submission Routing and Signoff

FAQs

Q: Will the IRB remain open during the transition from eProtocol to iRIS?
A: Yes, during the transition phase from eProtocol to iRIS, the IRB office will remain open during business hours, Monday through Friday, 8:00 a.m. to 4:30 p.m. The IRB office will continue to handle daily routine operations and process select submissions.

Q: What is iRIS?
A: iRIS is the online application system used to submit studies and all subsequent submission materials to the Institutional Review Board (IRB). iRIS 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.

Q: How do I access iRIS?
A:There are two ways to access iRIS. First, visit the McLaren Research home page at https://www.mclaren.org/main/research. Click on the + symbol next to the Research Integrity link on the left side of the screen. Next, click the link for iRIS that appears. The iRIS information page will appear with the link to iRIS at the top of the page. Alternatively, access iRIS directly at http://www.mclaren.imedris.net. You may bookmark this page for quick future access.

Q: Which internet browser should I use?
A: The current version of iRIS is compatible with all browsers, although Chrome is the recommended browser.

Q: Where can I get help on using iRIS? Will there be training?
A: In the weeks prior to launch, training modules will be posted online for self-paced viewing. Standalone PDF’s of training manuals for printing or saving will be posted simultaneously. Live webinar training sessions will be scheduled soon as well – stay tuned.
You may also select the “Help” button on your iRIS homepage to view a variety of educational topics.
After launch, contact the Research Integrity office at (248) 484-4950 or hrpp@mclaren.org.

Q: Do all submissions go through the iRIS system?
A: Yes, all submissions go through the iRIS system.

Q: In the Help window, I clicked to open a document/template/resource and a blank screen opened. Where is the file I’m trying to access?
A: All of the documents/templates/resources located in the Help area on the iRIS home screen open as a blank pop-up window first. At the bottom of this blank pop-up screen, you should see your file downloading. Once the download is complete, you may click on the file to open. Users should be able to access all files.

Q: Are users able to "Hide" studies via the "All Studies" table?
A: Yes, users may hide a study by clicking on the “Hide” icon under the “Actions” tab in the “All Studies” section of their Study Assistant Workspace. To find a hidden study, the user must change the search setting filter at the top right of the “All Studies” section header by clicking on the gray button with the small gear on it. Then, check the box next to “Show Hidden” in the drop-down menu of options. When the hidden study appears, the Actions icon that was formerly the “Hide” icon is now the “Show” icon. Click on the “Show” icon to un-hide the study.

Q: Are users able to retract submissions before the IRB assigns a review process?
A: Yes. If the form has been filled out but not yet submitted into the workflow (in “Pre-Submission”), a gray “Send Submission” button will populate in the “Task Name” column, allowing you to send the form without opening it. (Access this screen by clicking on the “Steps” button under the “Studies Submission Status” section of your Study Assistant Workspace.) If the form has been submitted into the workflow and has been received but not processed by the IRB (in “Pre-Review”), a gray “Retract Submission” button will populate in the “Task Name” column, allowing you to pull the form back to make any corrections. If the form has already been processed by the IRB, this column will be blank, and users may no longer retract the submission.