Accessing and Using iRIS

1. In your web browser, go to iRIS at sdsu.imedRIS.net
2. Login to the iRIS system using your SDSUid and Password, even if you are a first time user

What if I do not have an SDSU account?

1. If you do not have an SDSU affilated account you can request a new account
2. In your web browser, go to https://sdsu.imedris.net:444/ 
3. Once at the login page, click on Request External Account.                                             

   

4. Provide your first and last name, email address, and SDSU affiliation (name of PI or lab, study or protocol number)

(The Research Support Services team will approve this request, which may take up to 24 hours.)

1. Under My Workspaces (top left corner), hover over Study Assistant, then select Create a New Study

   

2. Select the applicable application

   

3. The form is a smart form and will show appropriate questions based on your previous answers.

   Once you have completed all of the form questions, you will see the notification below. Select OK

   

4. You are now viewing the Submission Packet to the Review Board. Here you can review the materials that will be sent to the Review Board. Select Save and Continue to Next Section to continue.

   Under 2.0 Study Application, you can select Edit/View to edit or view the application that you just completed. Otherwise, select Save and Continue to Next Section to continue.

   Under 3.0 Other Attachments, you can attach any additional documents to the review board such as permits, training documents, recruiting materials or Exposure Control Plans. Select Save and Continue to Next Section to continue.

   

   IRB initial applicants, Under 3.0 HRPP  Attachments, you can attach your reliance agreement with a reviewing IRB, participant recruitment material (i.e. fliers),  Measures, any documents relating to foreign investigators, or Data Management Plans, as well as any other relevant documentation.

   Under 4.0 Consent Forms, you can attach any materials that will be used to consent participants. It also includes a template builder for various participant groups and consenting situations.

   

5. If you are the PI, you will see an option to Sign off and Submit. If you are not the PI listed on the application, you can exit the form and the system will send a message to the PI to Sign off and Submit.

   

6. Select OK

   

7. You can view each item in a separate window by clicking the arrow next to the submission forms.

   In order to submit the form, you must answer the PI attestation, approve the submission, and click Save Sign off.

   

8. Once completed, the application can be viewed under Studies Submission Status - In Progress

   

9. The study will be routed to the an analyst of the relevant review board. Any comments from the analyst or review board will be communicated via an email from iRIS

Annual Continuations, Continuing Reviews,  Amendments, Adverse Events, Reportable Events and Personnel Change Forms can be submitted for each study in iRIS.

1. Find the appropriate study and click Forms

   

2. A pop up window will appear. Select the appropriate form to start a new submission.

   

3. Complete the form sections as needed. Once the form is completed, if you are not the PI, a message will be sent to the PI to Signoff and Submit the Form. If you are the PI, you will automatically be taken to the Signoff and Submit page to submit the form to the appropriate committee.

   

1. Under Tasks, the PI will receive a task stating that changes have been requested

   

2. This will take you to the Review Response Form. You can revise the application by clicking Revise Existing.

   Reviewer comments are called Stipulations. Each stipulation is listed under 1.2 Stipulations to Address

   

3. Select Confirm to create a revision

   

4. Make revisions directly in the application. The system will track changes.

   You can select Save Section and Back to return to the Review Response Form to select the next stipulation.

   

   5. In the Review Response Form, select Complete Action to indicate that the stipulation has been reviewed and revised. Indicate whether you accept the stipulation and provide a text response to the stipulation.

   Note: each stipulation must have a text response and cannot be left blank.

   

   Note: For best results, respond to each stipulation individually. Once the revision has been made, save the section and go back to the Review Response Form.

5. Once all stipulations have been addressed, select Save and Continue to Next Section

6. The PI will then be directed to sign off on the submission.

   

If you have registered to CITI with any email address other than your @sdsu.edu email address (ex. @mail.sdsu.edu), you can add an alternate email address to link your iRIS account with your CITI account.

1. In the upper right hand corner, click on My Profile > My Account

   

2. Under Additional Email Addresses, click Add

   

3. 3. Enter the additional email address and click Submit.

4. 4. Click Save Changes

   Note: You can choose to use the additional email address to receive system notifications from iRIS, if you prefer.

You can delete a form if the Review Board has not started processing it yet.

1. Go to My Studies and open your study.
2. If necessary, retract the submission you want to delete by clicking on the Retract Submission button and then click OK.
3. In the Submission Form column, click on the name of the form you want to delete (i.e. Amendment Form).

4. You will see a list of forms you have submitted. Check the box next to the form you want to delete and click the Delete Selected Form button.

   

Note: If the IRB has returned the submission for corrections, the form must be denied administratively in order to be removed.

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, co-PIs, co-investigators, or study contacts who are listed in section 3 of the initial Application.

Important Note: Only individuals listed in section 3 of the initial 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.

1. Go to View and Manage my Studies

2. Select the study

   

3. Then select the Study Management tab

   

4. Select Key Personnel

   

5. All Key Study Personnel (PI, co-Investigator, Research Staff, Faculty Adviser, Study Contact) that has been named for the protocol will be listed.

   

There are a few ways to access Forms:

1. Open the protocol of interest and Select from the Submission Form options below

   

   Then select Add a New Form from the options on the right (then scroll to step 3)

   

   or

2. Locate the BUA, IRB or IACUC record you want to amend/update and select Forms from the study dashboard.

   

   Select IBC, IRB or IACUC Personnel Change Form from the Forms list.

   

   or

3. Select the Start a Submission Form for one of My Studies from the Featured Study Operations list.

   

   Click on the Select a Study icon for the protocol you want to amend/update

   

   Select the form you want to submit against your protocol (Personnel Change Form).

   

On the Personnel Change Request

1. Select the option for Other Study Personnel, then select Setup Key Study Personnel Request

   

2. If adding personnel, enter the personnel last name and then select the Find User/Search Directory button. Personnel info will display, select to add.

   

   If removing personnel, select that option on the left and then select the name of the person you would like to remove from the protocol then proceed through the steps.

   

3. Select appropriate personnel option from drop down menu

   • Additional Investigators, if adding Co-Investigator
   • Research Staff, if adding Students or program coordinators
   • Contact, for personnel who will submit forms against your protocol

   Then click the Save button below.

   

4. Once you add the personnel, click the button below for Close Setup of Study Personnel.

   

5. Check the box next to the personnel name and select Save and Continue to move through the prompts to the PI Sign Off.

   

   For more information

Submission tracking is incredibly easy in the iRIS system.

• Go to the View the Submission History for one of My Studies section.
• Select the applicable study.
• View the Details next to the Reference/Study Number to drop down the work flow chart. 

You will be able to see which 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.

Yes. Open the form and click on the "Printer Friendly" button. You can then choose to print the form as an HTML form or a PDF form. Select "PDF Form" to save the form as a PDF.

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 Initial Application.

If you click to open your protocol and nothing happens, check your pop-up blockers.

Many browsers,  including Chrome, Edge, Internet Explorer, FireFox, and Safari have pop-up blockers such that most pop- ups never appear. Some toolbars (like the Google Toolbar) have pop-up blockers in them too.

Configure Pop-Up Blockers

Several features in iRIS rely on pop-ups, so you will need to configure your browser to allow pop-ups if you use the most current versions of Chrome, Edge, Internet Explorer, Firefox, or Safari

To ensure that pop-ups are allowed in iRIS, use the following steps to manually check your pop-up settings.

*Note: Other pop-up blockers from third party vendors and Internet Service Providers exist but are too numerous to list here.*

Chrome and Edge

When blocking a pop-up, Chrome and Edge display an icon in the address bar

When you click the icon in the address bar, a menu will display the following choices:

• A clickable link of the pop-up.
• Always allow pp-ups and redirects from <site link>
• Continue blocking

*It is recommended to allow pop-ups for the website if the website is trusted (such as iRIS)*

Firefox

In Firefox when you log into iRIS, you may see an information bar which is just above the web page content and below the toolbars. This bar may warn you that a pop up has been blocked.

Click on this bar and choose Options to configure Firefox to allow pop-ups. You will see a menu displayed that has the following choices:

• Allow/Block pop-ups for this site
• Edit Pop-up Blocker Preferences
• Don’t show this message when pop-ups are blocked
• Show <site address>

*It is recommended to allow pop-ups for the website if the website is trusted (such as iRIS)*

You may then also have to select the downloads in the address bar to find the item you wish to see.

macOS

Safari

When blocking a pop-up, Safari displays a message and an icon in the address bar.

Clicking the message or icon will open the blocked pop-up.

To permanently allow pop-ups, with the site you would like to allow pop-ups open, go to Safari > Preferences > Websites. On the left, scroll down and select Pop-up Windows.

Under Currently Open Websites, select the appropriate site and change the drop down to Allow.

Firefox

Add the URL (web address) for the iRIS entry page to the list of allowed sites. You can do that by selecting Settings in the Firefox menu, selecting the Privacy and Security tab, go to Permissions selecting the Exceptions button next to Block pop-up windows, and pasting in the URL: https://sdsu.iRIS.net/

1. Click the menu button and select Settings.
2. Select the Privacy & Security panel.
3. Go down to the Permissions section.
4.  Click the Exceptions… button to the right of Block pop-up windows to open a dialog box to choose which sites are allowed to display pop-ups.
5. Type or paste https://sdsu.imedRIS.net/ and click the Allow button to add it to the list of sites that will be allowed to open pop-up windows.
6. Click the Save Changes button to apply your changes.

No, turn off tracked changes before uploading your consent form.

iRIS includes an internal document comparison tool. You and the IRB can use this tool to see what changes were made in different versions of the consent form if you submitted MS Word documents.

To use this tool, open your study via My Studies. Click on the “Informed Consent” link from the study management dashboard. Click on the folder icon to see all of the versions of a particular consent document. Check the boxes next to the two versions you want to compare, and then click “Compare Consent Versions” button.

The comparison tool can also be used to compare different versions of the IRB Application, submission forms (such as the Modification Form) and Word versions of Other Study Documents.