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iRIS

iRIS Login: https://iris.hhchealth.org/

iRIS is short for Integrated Research Information Systems. It is a web-based system that enables online application submission, real-time submission tracking, review, post-approval compliance activities, and data management. It is used to process all of the research applications that are submitted to the Institutional Review Board (IRB). The system also functions as a document repository, providing investigators with easy access to submission records and study documents.

Investigators can use the system anywhere they have Internet access, helping to connect faculty, researchers, students and partners around the world in one portal. iRIS promotes a paperless office and supports and greener and cleaner environment.

iRIS Documentation

All iRIS documentation can be found in the iRIS system, under the help link located on the upper right corner of the screen within iRIS. Below is a list of some of the documentation you will find there:

  • A Quick iRIS User's Guide
  • Common Pitfalls in iRIS and How to Prevent Them
  • My Assistant
  • Study Assistant
  • Subject Management
  • Attaching New Document To Response Form
  • Attaching New Document To Correction Form
  • How to Sign-Off on Submissions
  • Tracking Submissions
  • Responding To A Correction Task
  • Adding a Continuing Review Form to an Existing Study
  • Managing Existing Studies (for project coordinators and principal investigators)

FAQs

Q: What is iRIS?
A: iRIS is short for Integrated Research Information Systems. It is a web-based system that enables online application submission, real-time submission tracking, review, post-approval compliance activities, and data management. It is used to process all of the research applications that are submitted to Institutional Review Board (IRB). The system also functions as a document repository, providing investigators with easy access to submission records and study documents.

Users will fill out their protocol submissions, route them for the necessary signatures and submissions will then be sent to the IRB. Submissions will be reviewed by the IRB within the system and approval documents will be issued within iRIS. Investigators can use the system anywhere they have internet access, helping to connect faculty, researchers, students and partners around the world in one portal. iRIS promotes a paperless office and supports and greener and cleaner environment.

The system includes application of agency specific validations to Grants.gov forms to ensure successful submissions to sponsor, the ability to merge data from system and user profiles, and proposal form values into Grants.gov and other sponsor forms, thus reducing input and enforcing data integrity.

In addition, the Clinical Trails Management module can manage all aspects of your study. Create a study schema associating your clinical and administrative procedures with your visits. Create multiple ARMS, visit window and duration for each visit. Upload your CPT codes to help develop your study budgets, set payment milestone rules and generate invoices top your sponsor(s). Full subject management including subject demographics, screening, study registration and visit tracking.

Q: How do I get access to iRIS?
A: The system's login page is located at https://iris.hhchealth.org. Researchers need to use their system user ID and associated password. Users can login on the right side of the screen.

Q: How do I know if I already have an iRIS ID and account?
A:

  • Your iRIS User ID is the same as your Hartford HealthCare logon userID and password. If you are an HHC employee and do not know your log in information or forgot your password, go to the I forgot my password page.
  • For students who not are paid in any capacity and cannot log in, please call 860.972.5621, during normal business hours.
  • If you are not affiliated with Hartford HealthCare, but you believe you should have access to iRIS, email iris@hhchealth.org as well.

Q: What internet browser(s) can I use?
A:

  • Recommended Browsers: Internet Explorer 9.0+ (Windows Only). (Internet Explorer 11.0 Preferred), Safari 6.0+.
    Supported Browsers: Chrome 30.0+, Firefox 24.0 +.
  • Internet Explorer (all versions): To ensure all (external) links work, go to: "Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK"
  • Safari: Built in pop-up blockers prevents various windows from loading (with no warning). Disable the pop-up blocker (instructions) or use another browser.

Q: What are the benefits of using the iRIS system?
A:

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

Q: What do I do if my login fails?
A: First, attempt to log in on the iRIS website. If unsuccessful or you still need assistance, call the iRIS Support Line at 860.972.5621, during normal business hours.

General Information

Q: How do I update or change my account information?
A: After login:

  • Click on My Assistant on the menu at the left of the screen.
  • Click My Account Information.
  • Click profile and edit as needed.

Q: How do I access the iRIS handbooks?
A: The iRIS handbooks are available for download by clicking the "Help" link in the upper-right corner of iRIS (after logging in), or by clicking here.

Q: How come some of the "Help" menu links don't work?
A: If you're using Internet Explorer, you will need to make the following change in your IE security settings in order for our external links to work: "Tools > Internet Options > Security (tab) > Internet > Custom Level > Scroll down to the "Display Mixed Content" option in "Miscellaneous" section > Enable > OK > OK." If you encounter this problem in another browser, contact us.

Q: How can I print a blank application form?
A: With the application open, click the Printer Friendly button.

Q: Why can't I edit my application?
A: 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.

Submissions

Q: Who can submit studies?
A: Only the study’s author; usually the PI, can submit studies. The primary investigator must sign off and submit new and continuing reviews and other study report forms. Other study submissions, e.g., SAE’s may be completed by others listed as Key Study Personnel (KSP) of the application.

Q: What do I submit via iRIS?
A: All new studies must be submitted to the IRB via iRIS. This includes new protocols, new chart review studies, new requests for exemption, new requests for determination of human subjects research and notifications of emergency use. Once your study has been approved and established in iRIS, all amendments, continuing reviews, adverse events, etc for that study must be submitted using iRIS.

Q: What are the deadlines for iRIS submissions?
A: Exempt and Expedited applications and their associated transactions are reviewed upon receipt. Full review submissions must be received by the IRB by the published deadlines. Full review submissions received after the deadline may be accepted on a case-by-case basis.

Q: How do I start a new protocol application?
A: On the left side of your iRIS homepage, there is a “Study Assistant” tab. Selecting the “Add a New Study” link and then the “HHC Main Research Application Form“ will take you into the protocol application. No matter what type of new study you have (clinical trial, chart review, exemption request, etc.) you will “Add a New Study” and the protocol application will branch you to the appropriate questions, based on your answers.

Q: Do I need to fill out the electronic protocol application all in one sitting?
A: You don’t have to complete the protocol application all in one sitting. You can start the protocol application and come back to it at another time, just be sure to select “save and continue” before you navigate away from a page. This will insure that the questions you have answered thus far are saved. Your incomplete submission will be in “draft” status and can be accessed by going to the “Study Assistant” tab (dark blue tab along the left) and then selecting “My Studies”.

Q: How do I assign a user to my key study personnel (KSP) when I can't find them in iRIS?
A: All KSP must be registered users of iRIS. If personnel do not appear in the lookup list of users:

  • At the login page, go to Request New Account and complete the entry form. If you have problems, please contact iRIS support at 860.972.5621.

Q: What do key study personnel have access to?
A: Key Study Personnel access varies based on their study role. For example, a principal investigator, co-investigator, and study coordinator can access both applications and documents. Study contacts will receive notifications and alerts.

Q: How do I get my new application signed by personnel and the department head?
A: Include them as Key Study Personnel. Each will receive an e-mail with instructions to review and signoff plus have access to all study documents.

Q: How do I obtain approvals/signatures?
A: iRIS uses electronic signatures. Upon completing your application you'll need to route it for approval to the PI and other appropriate individuals. Detailed instructions are available in the Submission Manual (available for download within iRIS) beginning on page 43.

Q: Why am I not seeing all of my studies?
A: You may not be able to see some studies because they have not been properly assigned to you. Contact the principal investigator (PI) and ask them to check for your name on their key study personnel list. If you are missing your own studies, contact the iRIS Support Line at 860.972.5621, during normal business hours, or email iris@hhchealth.org.

Q: Who can view/access studies?
A: Only individuals designated as KSP on the study and with appropriate “Role based access” Study access is usually limited to the PI, sub-I(s), KSP, study contact(s), IRB members and staff.

Q: How can I search for my studies?
A: You can search by Principal Investigator’s Name, the IRB number, the Study acronym/short title, Department, Study status (open, closed, etc.), the Submission Reference # or the Study Expiration Date.

Tracking Your Studies

Q: What is the Study/IRB Number?
A: iRIS system will automatically assign a 7-digit number to each new study submission. The IRB number is assigned when you submit to your IRB of record. 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 iRIS. e.g., HHC-2014-123 and the remaining digits are your study’s number, in sequence, with others studies submitted that year.

Q: When is an IRB # assigned?
A: IRB #s are assigned once an application is started and are visible in the top-left corner of the screen. The format is YYYY-NNN (4-digit year followed by a 3-digit number).

Q: How can I check the CITI status for all of KP on my study in iRIS?
A: To see the education history and e-mail addresses for all KP on the study follow these instructions:

  • To find the study, log in to iRIS, click on Study Assistant (on the left side of the screen), then on My Studies.
  • Select your study by clicking on the notebook icon on the left under "Click to open."
  • Click on "study mgmt." in the "Navigation" section of the header.
  • Click on the Study Management tab (on the upper left).
  • Click on Study Summary/Profile.
  • Click on the head icon next to each study personnel. The CITI status is under Education History. If the Education History is blank or only has expired courses, the KP will NOT pass the CITI check in iRIS.

Note that CITI status is synchronized via the e-mail address in iRIS. The e-mail address is under Contact Information on this page. Click the “Back” button (upper right) to return to the Study Summary/Profile page. Note that CITI status is checked for all study personnel unless they are ONLY listed as Study Contacts.

Q: How can I see where my submission is or why it is delayed?
A: "Track Location" will show the present disposition of your submission. It will display both the submission's past and pending events. Completed items are marked with a check mark while Pending items show an "In Process" icon.

  • Go to the Study Assistant tab.
  • Go to My Studies section and Click the applicable study.
  • Click to open on the "Submission History" link to check for more detail about where the study is in the review process.
  • Locate the submission you want to track, and click Track Location.

Q: How do I determine who has signed off on my submission?
A: The "Track Location" feature is the best method of finding this information. The submission signoff rows are marked complete once the user has signed-off. Also you will notice a time stamp of receipt and if signed you will see a completed time stamp on the "Date Received/Date Completed' column. The items that read "In Process" are pending.

Q: What is the Submission Reference Number? Where do I find it?
A: The Reference # is a unique identifier for any study related item submitted to iRIS. All submissions receive a Reference number. You can find the reference # located in the upper left corner of the many of study pages, and on your home page in the windows for Incomplete and Completed Tasks.

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 the original submission, a submission response or a document in the study history that is linked.

Study Documents and Consents

Q: Uploading Informed Consent and HIPAA Documents – Word or PDF?
A: Please send in Word format.

Q: I forgot to attach some documents. How can I do that now?
A: Submit an "IRB Submission Form" to send documents to the board outside of the original submission.

Q: Why doesn't anything appear when clicking a document icon when using a Mac computer?
A: Make sure your pop up blocker is not on while using iRIS. Turn it off in your internet browser settings for the duration of your time in the system.

Q: How do I create a revision of a documents?
A: Revisions are only allowed for documents that have already been submitted. First, you must find the document that you want a revision of then click the "Create a revised document" button that is next to it. The version numbers that are associated to the document will update automatically. *Caution, if you are asked to enter a version number then the revision process was not properly followed so you have to start over. The Revision function will also help assure that your documents are both organized and current. Remember to attach the documents to your submission.

Q: I have a study document I want/need to attach but I wasn’t asked for it when I was putting together my electronic submission packet?
A: If you have a study document or Department Review Committee approval letter that you would like to include with your submission (but you were not specifically prompted for it) you can attach the document(s) in the last section of the submission packet, “Study Documents”. This section will show you the study documents you have attached thus far (minus consents or assents) and give you the opportunity to attach anything else you need to include with your submission.

Q: How to make changes to the consent document?
A: To make changes to the consent document create a new version of the approved document.

Q: Can I submit a translated version of the consent?
A: Yes, a translated version of the consent document may be submitted using a Modification form. Consent and HIPAA initial documents and subsequent revisions must be submitted in MS Word format. Documents submitted in MS Word format are compatible with the document comparison feature in iRIS. The document comparison feature allows direct comparisons between version revisions of the Consent or HIPAA. PDF format versions are NOT compatible with the comparison feature.

Q: Uploading Study Documents - Word or PDF?
A: Both are acceptable.

Q: IRB Approval Stamp?
A: IRB Approval is affixed and visible on IRB approved informed consent, HIPAA and selected study documents. The IRB stamp will display the Hartford Healthcare logo, IRB or Study #, Approval Date, and may include an Expiration Date. Please leave appropriate page margins, 1.25” at the top/bottom of each page to accommodate the stamp.

Q: How do I submit Continuing Reviews, Modifications, Adverse Event reports, protocol deviations or other post approval reports?
A:

  • Go to the "My Projects" tab and open your active study.
  • Under the Submissions tab, select the name of the form that is needed.
  • Select Add New Form tab to complete a new form.

Remember to SAVE your work frequently. Unsaved work is not retained and will be lost.

Q: Can I delete a form or study application that is no longer needed?
A: Yes, you can delete an un-signed DRAFT form if the IRB has not started processing it yet. You cannot delete a form or study document that has been submitted, reviewed or approved by the IRB.

Q: Why can't the review board (IRB) see recently uploaded documents?
A: The Review Board can only see "submitted" documents. Your uploaded documents are kept in your study's file and the Review Board cannot access them until they are submitted. Therefore, remember to attach and submit those documents that you want the Review Board(s) to view.

Correspondence

Q: How do I respond to iRIS correspondence?
A: Open the study the correspondence is referring to and click "Study Correspondence." Click "Post a Reply to this Topic" to respond. For example, if you receive an e-mail from iRIS in your Outlook, Gmail, Yahoo, or other email account, clicking "Reply" will send your message to the general iRIS inbox and not to a specific person. To properly reply, you must do so within the iRIS application.

Q: My protocol was submitted in iRIS but I haven’t heard anything yet from the IRB. What has happened?
A: You can always check the status of your protocol by clicking on the “My Studies” link in iRIS. Refer to page 46 of the Researcher’s Handbook (available for download from the iRIS help menu) for further guidance. However, there are three things that must happen before your protocol is received by the IRB:

All designated signatories (usually the PI and his/her department chair) must approve the application. They will need to log in to iRIS to do so. Please note that the application does not need to be sent to Other Investigators or Research Support Staff.

All Investigators must have an electronic COI disclosure on file. All KP must satisfy the human subjects research education requirement.

Q: What is the submission response form?
A: The Submission Response Form is a communication tool that provides a method for the Review Board to request additional information from the Investigator.

Q: I received an email saying a submission response form was pending, but where do I find it?
A: The Submission Response Form is found either under the Incomplete Tasks or the Outstanding Submission section found in Study Management of iRIS.

Q: How do I know if the review board has received my submission?
A: Open your study, click Submissions History then click the Track Location icon next to your desired submission. Review the events for the submission receipt.

Q: Why do I continue to get sign off notifications even if I have already signed?
A: You will continue to be notified so that all involved will know of any outstanding issues until all signatures have been completed, including the chair.

Q: How do I know I have signed off correctly?
A: If you have no outstanding tasks on your home screen then you have done what was expected of you.

Q: How can I find out who has not signed my project?
A: You will continue to receive notices until all signatures are captured. But to see 'who' has not signed, click on the track submission icon and you will see who has not completed the signature. You can also tell because they do not have complete time stamp.


Research