New Clinical Research Systems Update - May 2018

Tuesday, May 15, 2018
By Duke Office of Clinical Research

OnCore Community News
iRIS Community News


OnCore Community News

What is OnCore?  OnCore is the Clinical Research Management System (CRMS) developed by Forte Research Systems that will support clinical research activities at Duke.  OnCore will provide enhanced clinical research study management, robust reporting, enrollment tracking, and accurate clinical research billing.  Beginning May 21st users will access OnCore at the following website:  oncore.duke.edu.  Note that this site will not be accessible until Monday, May 21st. 

Data Migration to the OnCore System Begins on Wednesday, May 16th at 5:00 PM

Data Cleanup—Please complete by June 20th

There are a several data elements that could not be migrated but are part of the Duke minimum required data set in OnCore. A set of instructions for protocol information are posted for study teams to use when updating this data in OnCore.  You can find Study Clean Up Instructions on the DOCR OnCore Support Page under the “Additional OnCore Job Aids and Tips Sheets” section.

For studies that are open to accrual, please review demographics, status and status dates.  For studies that are closed to accrual or closed with the IRB, please review participant’s status to ensure accuracy.

DOCR OnCore Support page

What about participants that weren’t entered in eResearch or Maestro Care?

Enrollment logs are being collected and will be migrated at a later date.

 

Institutional Approval will Take Place in OnCore

Institutional approval will take place in OnCore.  The components of institutional approval include: IRB approval, ORC (contract) completion, RDSP approval, SOM Finance signoff, and DOCR approval (which will include budget and calendar signoff and Maestro Care Beacon/order set build).

Studies that a have IRB approval but a status of “Awaiting Final Approval From DOCR” or  “Awaiting Fully Executed Contract” will be given administrative approval in order to be migrated into OnCore.  This does not constitute institutional approval to open to accrual.  OnCore will be updated prior to go-live to indicate the accurate status.  An email will be sent to the PI and primary study staff prior to “approval”.

 

Maestro Care

Any new consents, new patient enrollments, or changes to status that are made in Maestro Care after 5:00 on Wednesday May 16th will need to be manually entered in OnCore on Monday, May 21st.

For studies that do not have charges/orders in Maestro Care, you can wait until Monday, May 21st to enter the consent in OnCore. 

For studies that have orders/charges in Maestro Care, you will have to enter in both locations.

Starting May 21st, the Maestro Care Patient Research Studies activity will change.  You will continue to add a timeline to DUHS Billing studies and enter comments necessary for clinical/research workflows, BUT YOU WILL NO LONGER enter new patient study associations or change patient association statuses.  All new patient study associations and any status changes are made in OnCore moving forward.

 

Participant Study Status

If the participant’s medical record is open in Maestro Care, a new study status will not come over from OnCore.  Close the medical record and select the Submit button in the OnCore Subject Console again.  Please refer to the Participant Status Flow diagram to determine what status should show in each system.  You can find Participant Status Flow diagram on the DOCR OnCore Support Page under the “Additional OnCore Job Aids and Tips Sheets” section.

 

Policy Revisions

The following policy revisions are effective May 21, 2018:

The Enrollment Tracking of Participants in Clinical Research is now the Registration of Clinical Research Participants Who Provide Informed Consent.  All participants who consent need to be entered in OnCore.

Participant Status and Study Visit Documentation in OnCore has been added. 

 

Training

We encourage staff to complete their training modules in the LMS and start using the OnCore Training playground.

NOTE: 

  1. Users who complete training BEFORE Wednesday, May 16th EOB will be added to OnCore in time for Go-Live on Monday, May 21st.
  2. Users who complete training AFTER Wednesday, May 16th but BEFORE Go-Live on Monday, May 21st will receive access to OnCore the week of Go-Live (but not necessarily by Monday, May 21st).
  3. Users who complete training AFTER Go-Live must use the Service Now process to request OnCore access.
  4. For those who were involved in feedback and testing of the OnCore training modules prior to April 9th, the modules have significantly evolved since this time and OnCore access will only be granted for modules completed after the April 9th official launch date.

REMINDER:  Access to OnCore is based on the role requested by a users’ CRU and successful completion of the training module associated with that role.

 

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

 

OnCore Financials Roll Out Plan

OnCore Go Live is May 21st!  At that time, we will begin our OnCore Financials roll out plan.  This plan was developed with the help of our Pilot Group, which consists of 6 CRUs.  In general, the roll out will be phased, with a new group of CRUs starting every 2-3 months.  The first phase of the SAP Interface is planned for the Fall of 2018.   For details regarding OnCore Financials roll out and what to do while you are waiting for your turn, please see the OnCore Financials Roll Out Plan slides.  The OnCore Financials Roll Out Plan slides are located in Box.  Please log into Box to view the slides.  For any questions regarding OnCore Financials or the roll out plan please contact Catee Mullen in School of Medicine Finance at catee.mullen@duke.edu

With the implementation of iRIS and OnCore, the research workflow was designed to limit the change that you and your staff experience.

  1. New studies will start in iRIS (the new IRB submission system) much like they start in Click eIRB today.
  2. The interface between iRIS and OnCore will create the new protocol in OnCore to minimize duplicate data entry.
  3. Once your IRB submission is completed and sent for PI signoff, OnCore will be ready for your team to enter additional data and upload documents to facilitate the DOCR Study Start-Up process.
  4. RDSP will occur in eGRC (see notes below in the iRIS section for details).
  5. Once IRB approval occurs, the information will push into OnCore and the rest of the Institutional Approval process will happen in OnCore to allow the study to open to accrual.

If you have any questions, please reach out to DOCR.help@dm.duke.edu.

 


iRIS Community News

 

What is iRIS?  iRIS is the electronic IRB (eIRB) developed by iMedRIS to be used for the submission, review, assessment, and approval of all research at Duke University including human participant-based research. Submissions include new protocols, amendments, safety events, renewals, and closure thus supporting the needs of the clinical research community within DUHS.

Users will access iRIS at the following web address on Monday, May 21st:  iris.duke.edu

 

Data Migration from eIRB to iRIS

Data migration from eIRB to iRIS will begin this Friday, May 18th at 5:00 pm.  At this time, the eIRB (Click) system will be taken offline and will not be available to end users.

eIRB (Click) will be restored with read-only access on Monday, May 21st at 8 AM, coinciding with the iRIS system Go Live.

To answer questions regarding the migration of data from eIRB to iRIS, the IRB has created a Data Migration from eIRB to iRIS FAQ sheet that is posted on the IRB website.  This FAQ includes a list of what data fields will migrate including time frames for data migration.  Please see the Data Migration from eIRB to iRIS FAQ for information about data migration between the two systems.

 

iRIS Study Migration will Occur in Three Phases

Study data that currently resides in eIRB needs to be migrated to iRIS.  The DUHS IRB Migration Amendment Form is an important part of the entire data migration process between these two systems.

The first phase of data migration is information that is considered part of the “study shell” (Title, PI, co-PI, Short Title, full study team, submission history) was migrated into the system by iRIS Administrators and will be viewable in the iRIS system at Go Live on May 21st.

The second phase of data migration is Study Documents.  Study documents will be prioritized for migration according to study status as follows:

  1. In-Progress Submissions that have reached the DUHS IRB (New, CR, Amendment, etc.)
  2. All Study Documents for Active Studies, with the nearest CR Date going first
  3. All Documents for Closed Studies from January 1st 2013

Documents will migrate over in the format (.pdf, .doc, etc.) in which they existed in eIRB.

Study documents will be migrated into the system by iRIS Administrators and will begin to appear through the end of May and throughout June.

The third phase of data migration involves the study team and will occur through the submission of a “DUHS IRB Migration Amendment Form”.  This form will be completed at the same time as submitting a study’s first amendment, safety event, or continuing review (CR) in iRIS.

The first submission will be a “Migration Amendment” to complete the iRIS study submission form.  Please do not upload study documents in this amendment; all approved documents will be migrated over prior to June 30.  This amendment will be clearly labeled in iRIS as a “Migration Amendment” and will bypass all institutional reviews, including CRU review.  When the PI hits the submit button, the Migration Amendment will come directly to the IRB.  Once that amendment is approved by the IRB, the second submission will be the amendment, safety event, or CR and the most recently approved study documents relevant to the submission.  For example, if an amendment is revising the protocol and consent form, study teams only need to upload the red-lined protocol and consent.  All other most recently approved study documents will migrate over throughout May and June.  Because of volume, the IRB requests study teams not immediately file Migration Amendments unless a regular amendment, safety event, or CR needs to be submitted.  No revisions to IRB- approved documents can be made via the Migration Amendment.

 

Institutional Approval takes place in OnCore, not iRIS

A major difference in workflows between eIRB and iRIS s that IRB approval will be issued from iRIS, but institutional approval will be issued from OnCore.  Once IRB approval is issued, study teams may initiate interim study activities as described in the IRB policy, but cannot recruit or consent subjects until institutional approval has been issued.

 

iRIS (IRB) End User Training is now available!

The online training course Introduction to Submitting an IRB Application in iRIS is now available to the research community.  The course may be found in the LMS.  While the training is not required, anyone who anticipates doing work in the iRIS system will find the module relevant to their workflow.  To register for the course and for additional information about the iRIS implementation, see the DOCR iMedRIS Support Page and select “iRIS Training Opportunities”.

The May 9th Research Wednesdays session presented by the Office of Research Informatics and the Duke Office of Clinical Research was dedicated to training end users in the iRIS system.  A recording of this session is available for anyone who was unable to attend the session or who would like to watch it again for future reference.

For questions regarding the iRIS system, please contact the iRIS team at iris@duke.edu in the Office of Research Informatics (ORI).

To assist end users, an FAQ sheet on “Data Migration from eIRB to iRIS” has been posted on the IRB website.  This FAQ contains details regarding the transition from eIRB to iRIS and the migration of studies from the old system to the new.  The FAQs will be updated as Go Live approaches.

 

RDSP to Reside in eGRC

As part of the eIRB migration on May 21st, the Research Data Storage Plan (RDSP) will be migrating into the Enterprise Governance, Risk and Compliance platform (egrc.duhs.duke.edu).  All existing, currently approved RDSPs will be migrated into read-only legacy records in eGRC for historical perspective.   If you have an approved RDSP and do not need to make changes, then no action is required of you for RDSP during the migration.  As you need to make changes that affect data storage, you will be able to search for your existing protocol and fill out a new RDSP for review. If you are starting a new IRB application, the last question will have a link out to eGRC where you can complete the RDSP.

RDSP reviewers are currently being trained on how to review RDSP submissions.  If you’re familiar with the RDSP, you’ll note that there are some clarifications that have been made to the questions.  Both staff and reviewers have been asking for some time for better, more discrete questions and we have taken this opportunity to improve upon the data storage questions.

During the go-live, staff will be available to answer technical questions about how to access eGRC, edit and save forms, and submit for review.  Questions about clarification on how to answer specific questions should go to the CRU/Research reviewers, all of whom will be trained.  A large staff training will be available in the weeks following the go-live.  We expect very few people will need to make immediate updates to an existing RDSP or submit a new one, but we will be working with them closely and using the Research Data Storage Plan (RDSP) Submission Instructions posted on the DOCR iRIS Support Page  in the “iRIS Tip Sheets and Job Aids” Section to see if there are additional improvements that can be made before the all staff session.  Thank you for your patience and collaboration as we roll out this joint migration.

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.

DOCR iMedRIS Support page