OnCore Community News
iRIS Community News
OnCore and iRIS are Live!
Here are a few helpful tips from the OnCore/iRIS Command Center to facilitate your use of these systems.
OnCore Community News
Having Trouble Logging into OnCore?
Now that Go Live has passed, all requests for OnCore Access are being handled through ServiceNow. If you do not have access to OnCore or are having difficulty logging in, please submit your access request via the ServiceNow form as follows:
Go to https://duke.service-now.com/ess/home.do
Select Get IT > Accounts & Access > Account Access Order Guide > OnCore – CRMS
OnCore Questions and Answers
Question: I’m trying to Consent a subject in OnCore, but the correct Consent version is not displaying.
Answer: All subjects were migrated with a “migrated consent” in the details of the initial IRB submission. No action is required unless the consent date needs to be updated.
Moving forward, consent details will come over from iRIS. Until that happens, the details of the current consent can be added to the IRB review details. A regulatory coordinator or anyone with regulatory access can update the details section on an IRB review. A Migrated Study Adding Consent Information tip sheet has been posted on the OnCore support page with instructions for adding consent details to and IRB review.
Question: I’m trying to access OnCore, but I keep receiving a blank page.
Answer: Access to OnCore from outside the Duke Medicine network requires a VPN connection. Be sure to connect to the Duke Medicine VPN and try again!
Question: I don’t see my subject calendar in OnCore
Answer: If you don’t see a subject calendar in OnCore, your protocol may not have a calendar built yet. From the PC Console, look along the left-hand side of your screen. If you see the “Protocol Calendar” tab, a calendar has been attached to your protocol. If you think you would benefit from tracking subject visits in OnCore, email DOCR-Startup@duke.edu to discuss a calendar build.
OnCore TIPS, TRICKS, and DON’T FORGETS
TRICK: If a patient status change does not show in Maestro Care, try closing the PT research studies page in Maestro Care and click the submit button again in OnCore.
DON’T FORGET: When putting a subject On Study, don’t forget to enter a Sequence No. (subject’s study ID #) for the subject if the sponsor has assigned one. This is important for Sponsor Invoicing! See image below:
TIP: When registering a Duke subject in OnCore, be sure to search for them first! This will pull the correct demographic information from Maestro Care and allow the subject to properly sync between the two systems. If you can’t find a subject via this search that you know exists in Maestro Care, do not create them manually in OnCore—instead, submit a ticket to the Duke Medicine Service Desk for the OnCore team to investigate!
Support
Please visit the DOCR OnCore Support page for FAQ’s, tip sheets and support information to assist with the transitions to the new systems.
For all questions around Go Live, contact the DHTS Service Desk. Users may also call the Service Desk at 684-2243 and select option 4 for Research.
iRIS Community News
The DUHS IRB Migration Amendment
A migration amendment involves the completion of the full iRIS application, and the information entered in iRIS must be the same as the information that appeared in eIRB.
Question: Do I need to submit a Migration Amendment to the IRB?
Answer: Submit the Migration Amendment only if you have an upcoming Continuing Review or Amendment that you need to submit. Wait to submit the Migration Amendment if you do not have a Continuing Review or Amendment that you need to otherwise submit now.
Note: No changes are permitted via the migration amendment
The DUHS IRB has created a Post Go Live FAQ sheet on the Migration Amendment. This FAQ addresses questions such as when do you need to submit a Migration Amendment and what do you need to submit if your study was under review at iRIS Go Live. For answers to questions regarding the DUHS IRB Migration Amendment, see the IRB website.
Key Personnel Changes
Key Personnel (KP) changes will be entered in iRIS and this information will push to OnCore. Please submit a Service Now ticket to have NEW Clinical Research Coordinators or a NEW Principal Investigator added to the Users and Providers section of the Research Administration record of Maestro Care. Research contacts will no longer be added to the Maestro Care record because the information needed at the protocol level can be found in OnCore.
iRIS Training and Tip Sheets
Would you like an online module to walk you through an iRIS System Overview? Do you need a tip sheet to assist you with topic such as:
- Submitting a Migration Amendment Form
- Logging in and Features of the iRIS Home Screen
- Navigating the iRIS Home Screen
- Protocol Application and Branch Logic in iRIS
- Getting Started Submitting a New Protocol Application
- How to Know:CRU or OO?
- Research Data Storage Plan (RDSP) Submission Instructions
- And Many More!
Visit the DOCR iRIS Support Page for training links, tip sheets, and links to where to go for help.
Research Data Storage Plan Migration Update
The Research Data Storage Plan (RDSP) migration to eGRC has been relatively successful. All existing approved RDSPs for open protocols were migrated into eGRC and are searchable. New submissions can be entered at egrc.duhs.duke.edu. There will be an all-staff open RDSP training session on June 4th from 2 PM -4 PM in Duke North 2001.
iRIS TIPS, TRICKS, and DON’T FORGETS
Migration Amendment Tips
- Please do not enter a migration amendment unless you have an upcoming regular amendment or continuing review that you need processed
- Migration amendments should ONLY contain information that was previously approved by the IRB. Since the submission form was updated, please fill it out to the best of your ability. You may use N/A and provide an explanation if something does not apply.
- Safety Events: migration amendment is not required
- Exempt: migration amendment not required. The submission can be updated via a regular amendment if you otherwise need to submit an amendment
- You can change Key Personnel without submitting the migration amendment
- Except in the case you are adding an external KP
Additional iRIS Tips
- Any studies that had not reached the IRB queue prior to migration were changed to pre-submission and will need to be resubmitted after completing the application in iRIS. (includes anything that was in CRU or specialty committee review)
- Any amendments or new studies that were in process and with the IRB in eIRB when migration occurred will be returned to the study team with instructions to complete the submission form
- When entering the Blood Draw amount on the Protocol Application, please round up to the nearest whole mL.
- Several forms, including Final Report and Adverse Event, are having adjustments made to address issues.
- If you are having trouble printing, check to ensure your browser’s pop-up blocker is disabled or allows pop-ups from iRIS.
- Several users have reported issues with inserting images into forms. This is being investigated.
- There was an incorrect link in the signature of system notifications from iRIS. This has been corrected.
- iRIS currently allows only one open session per browser. You may open a second session in a different browser as a workaround.
- Copying and pasting the Research Summary from eIRB into iRIS caused a problem with footnotes and endnotes. You may paste the endnotes into the last section. We are working on a solution to this problem.
- Due to issues with single sign-on, users cannot currently access iRIS from myRESEARCHhome. Additionally, protocol data displayed in the myProjects widget is coming from Click eIRB, which means the reported data is not current. ORI/RAD is working with iMedRIS on a solution.
- IRB data that is fed to Sponsored Projects System (SPS), Research Compliance Tracker (RCT), LabVantage is coming from Click eIRB, which means the reported data is not current. ORI/RAD is working with iMedRIS on a solution.
- IRB data that is fed to DEDUCE is coming from Click eIRB, which means that access to DEDUCE may be granted or blocked in error. ORI/RAD is working with iMedRIS on a solution.
- If you cannot find someone when adding KSP, have the user log in to the system. For users that were not migrated in on studies from the old eIRB system, iRIS accounts are automatically created when they first log in, and they will then appear in the look-up.
Need iRIS Assistance?
Contact iRIS@duke.edu for iRIS end user help.
Contact docr-training@dm.duke.edu for assistance with iRIS training.
For all questions around Go Live, contact the DHTS Service Desk. Users may also call the Service Desk at 684-2243 and select option 4 for Research.