NEW Epic Workflow for Resolving Inactive MRNs when Registering Subjects in OnCore
Date Issued: October 16, 2023
Effective October 13, 2023, The Office of Research Affairs (ORA) and the Epic Grand Central (EGC) Team introduced a new workflow requiring study teams to directly reactivate an inactive research patient Medical Record Number (MRN) in Epic Hyperdrive. The improved workflow removes the initial step of study teams opening a Help Desk ticket and/or possibly engaging personnel to further assist. Instead, study teams can follow the steps outlined in the Epic Newsflash. This new workflow (“Retrigger A31 for OnCore”) provides study teams with the autonomy to directly initiate the process of reactivation of an inactive MRN in Epic Hyperdrive.
What was the previous workflow and what has changed?
Prior to October 13, if study teams were unable to complete subject enrollment in OnCore due to an inactive MRN, they opened a ticket in the Epic Hyperspace. If they received an error and were unable to open a ticket, they emailed Priya_Mishra@rush.edu with the required information, and a ticket was opened on their behalf. The ORA and EGC partnered to reactivate the MRN and emailed study teams when enrollment could begin. On occasion, departments could be penalized for not adhering to The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy formerly referred to as the OP661 Policy for enrolling subjects within one (1) business day of receiving the signed Informed Consent Form. The new process allows study teams to initiate the reactivation of an inactive MRN directly in Epic Hyperdrive without assistance from the ORA and the EGC. A31 refers to the specific technical interface that connects these two systems and allows the MRN to transfer from Epic into OnCore.
For questions regarding this process or OnCore, please contact OnCore_Team@rush.edu
NEW! Changes to the Master Project and IRB Workspaces in the Rush Research Portal
Date Issued: September 15, 2023
Effective September 15, 2023, the Master Project and IRB Workspaces in the Rush Research Portal (RRP) contain NEW fields! These changes were implemented to ensure the transfer of data from the RRP into OnCore is complete and more accurate, but also to eliminate the need for duplicative and manual entries across our interfacing systems (including Vestigo).
The updates to the Master Project include:
Entering the Project Title in (potentially) two places instead of one, if your study is being “Pushed to OnCore”.
Continue entering the abbreviated title (255 characters or less) in the Project Title field, section 1.0. as you were previously.
NEW: Enter the project title as listed in the official protocol document (no abbreviations or acronyms) in the Long Title field, during the “Push to OnCore” (255 characters or more). Data entered in this field is transferred from the RRP into OnCore and from OnCore into Vestigo, Rush’s new web-based system created to manage investigational drug products used in Rush studies.
Including a Short Title for your project is now mandatory. The Short Title field has always appeared in the Master Project; however, populating this field is now mandatory and the data entered transfers directly into Epic for clinical research studies.
During the “Push to OnCore”, new Staff roles can be added. To add staff during the Push to OnCore, the staff member must have been previously added in the Master Project. If not, the staff name will not appear as an option to add. Adding staff in this section is not required; however, doing so will ensure the staff name and role are transferred directly to the Staff tab of the PC Console in OnCore.
Additional fields have been added to the Clinical Trials Information Section. If you indicate that your project is a clinical trial, additional questions will appear. Further information will be requested based on how you complete the smart form. The data will then be transferred directly to OnCore.
The updates to the IRB Workspace include:
Section 15.2 Consent Forms and Process of Consent - The Rush consent/authorization template has been updated to include a summary, instructions, descriptions, sample consent language, key definitions, and resources regarding the NIH Policy for Data Management and Sharing (DMS Policy) and how that information must be disclosed in the consent document. The DMS Policy applies to grant applications submitted to the NIH on or after January 25, 2023. The HIPAA section has also been updated to add a statement for studies where health information will not be shared with anyone outside of Rush and the Rush IRB has been removed from the list of entities that health information may be disclosed to.
Section 16.0 – Data Privacy & Confidentiality – Question 10.0 asks whether a Data Management and Sharing Plan is required by the NIH for the study. If answered in the affirmative, there is an upload button in 11.0.
Section 16.1.1 – HIPAA Forms – A new HIPAA form titled “Alteration of HIPAA Authorization in Research Request Form” was added. Also, minor edits were made to the three of the existing HIPAA forms, but nothing impacted user experience.
For further questions regarding these changes, please contact:
RRP@rush.edu for questions regarding the changes in the Rush Research Portal
OP-661 Policy: Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS)
Date Issued: September 5, 2023
The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy (former policy number OP-661) was recently updated by Corporate Compliance, effective August 17, 2023.
The purpose of The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy is to ensure that study participants’ information and related study activities are entered into OnCore without delay so that the clinical services provided to them as part of their study or trial are billed to the correct financially responsible party as detailed in the study’s Coverage Analysis.
The updates to the policy provide clarification and reflect changes in our clinical research workflows since its initial publication. Please review the new version of the policy in PolicyTech, the policy and procedure management system used at Rush. Rush personnel can easily navigate to PolicyTech via the Inside RUSH page.
Please contact OnCore_Team@rush.edu for questions about OnCore and Priya_mishra@rush.edu for questions regarding the recent changes and overall adherence to this policy.
Rush’s Annual Conflicts of Interest (COI) Survey Launches the Week of July 10
Date Issued: June 28, 2023
The RUSH Conflicts of Interest (COI) survey launches the week of July 10. The COI survey provides RUSH employees, faculty and staff the opportunity to report outside professional activities and innovation. The survey process helps protect your work and reputation and underscores excellence in what we do. It serves as a reminder to conduct affairs in ways that exemplify the RUSH mission and ICARE values and safeguards RUSH as an institution of public trust.
RUSH's COI policies are designed to ensure that individuals disclose outside relationships, and that RUSH appropriately manages or eliminates situations in which personal or familial interests might otherwise compromise or appear to compromise individuals' objectivity as caregivers, teachers, researchers or administrators.
What to Expect
Beginning the week of July 10, based on your role you may receive an email with instructions to complete the COI survey. To determine if your role meets these criteria, please click here. All employees and faculty are subject to the COI policies and vendor guidelines and are still required to report any applicable relationships or activities, as outlined in the policy and/or vendor guidelines, to both your supervisor and the COI Office.
In the event that you do not receive the survey, and have something to disclose, please contact the COI Office.
Important Dates to Remember
COI Survey Launch Date: Week of July 10th
COI Survey Due Date: July 28, 2023
COI Survey Launch Date for Board Members and Residents: August 1, 2023
The COI and Commitment policy has been revised. An overview of the new additions to the policy is available here.
For further details, please access the PolicyTech page and search for the following policies:
Conflict of Interest and Commitment.
External Relationships and Financial Conflicts of Interest in Research
The COI guidelines for working with vendors are available here.
For technical COI survey issues, send an email to Help@rush.edu.
If you have questions about the survey's content or policy, please contact the COI Office at (312) 942-5303 or COI_Office@rush.edu.
Responsible Conduct of Research In-Person Training
Date Issued: September 1, 2022
The Office of Research Compliance (ORC) will again offer live Responsible Conduct of Research (RCR) training. The NIH has revised the RCR training regulation (NOT-OD-10-019) requiring an increase from 10 to12 sessions. The topics in this program will be presented by content experts and have been created to fulfill federal funding requirements (e.g., National Institutes of Health (NIH)) for formal instruction for those obtaining career development, research education, and dissertation research grants. RCR training is also open to any interested research personnel.
Along with completion of the 12-series coursework, the CITI Program RCR must be completed as a prerequisite to receive a Certificate of Completion. The training sessions will be held on Wednesdays beginning September 21st through October 26th from 9-10:30 a.m. via WebEx and will allow for instruction in two content areas during each session. Learning Hub registration is required. Read more.
The Pre-Award Grant Submission Playbook is now available!
Date Issued: May 13, 2022
The Pre-Award Grant Submission Playbook is a guide for navigating the pre-award process for federal grant applications through Sponsored Programs Administration at Rush. This document was created in direct collaboration with process owners and key stakeholders amongst several departments as part of a Pre-Award Standard Work Event. It will be updated and augmented as necessary. Playbook resources include:
A simple, one page pre-award grant application timeline which highlights the three key standard work deadlines for departments and PIs:
Chapter 4: Budget Creation and Commitments (Grant Administrator)
Chapter 5: Budget Consultation (SPA Grant Specialist)
Chapter 6: Compilation of Documents / Finalizing the Application (Grant Administrator)
Chapter 7: Department Review (Department Chair)
Chapter 8: SPA Review / Submit to Sponsor (SPA Grant Specialist)
We hope you make use of this new resource. Please reach out to Jennifer Garcia and Jackie Rollin with additional questions.
Location: RRP > Grants > Pre-Award Grant Submission Playbook
RRP vs MediTract Research Contracts One Pager Available!
Date Issued: December 9, 2021
Rush Legal is now utilizing MediTract to streamline its process for submitting and reviewing legal agreements. While research agreements will continue to utilize the Rush Research Portal (RRP) for submission and review of research agreements, any agreements considered ancillary to research will need to be uploaded into MediTract.
Please reference the newly created document for assistance with this new workflow which includes:
A description of each platform (i.e. RRP; MediTract)
A brief overview of how to determine whether an agreement should be sent to MediTract or to the RRP
Examples of the types of agreements that should be uploaded into each platform
Please reach out to Kelli Jones with additional questions regarding this document.
Financial Review Sign-Off (FRS) Document is Now Available!
Date Issued: September 27, 2021
Financial Review Sign-Off (FRS) Document has been posted. Located: Rush Research Portal -> Clinical Research Administration -> OnCore System News and Information -> Financial Review Sign-Off Doc. This document entails FRS overview and access request process and, CA and calendar review checklist for FRS. Additionally, we also posted the FRS approval list by department. Location: Rush Research Portal ->Forms and Documents-> Financial Review Sign-Off (FRS) Approver List.
Please reach out to Priya Mishra with additional questions about this document.
The Business and Payment terms updated excel Version 1.0 is Now Available!
We edited several terms, added more terms to negotiate on and provided other useful information related to business and payment terms. This is a live document and will be updated as needed. The updates will be posted as next version on portal. Listed here are the new additions to this document:
Necessary procedure under invoicing category
Non- procedural cost under invoicing category
Dispute final payment under payment category.
Query resolution (payment/ final payment) under payment category
Added more details to remittance address both for CRB and non- CRB studies
Added list of questions which legal have for study team in main body of contract
Added a draft on “Note to sponsor”
Please reach out to Priya Mishra with additional questions about this document.
The SOP outlines the process to monitor and assess investigator compliance with regulations and Rush policies relating to Informed Consent (IC).
Criteria for review include the following:
The study is newly approved by the IRB (First 3 consents will be reviewed)
Individuals obtaining consent who are new to Rush or new to obtaining research consent (First 3 consents will be reviewed)
Required re-consenting of study subjects (ie. amendment approval or IRB decision) (First 2 re-consents will be reviewed)
A COI Management Plan was issued and requires the ICF to be amended and, if necessary, the re-consenting of currently enrolled subjects (First re-consent will be reviewed)
If unsatisfactory results are obtained, monitoring will continue until demonstrated successful passing of all elements of proper ICF execution is obtained.
The review is performed remotely either through REDCap (for studies registered in OnCore) or email submission (for studies not registered in OnCore). If the study is not registered in OnCore, an ORC staff member will contact the research team to notify them that ICF review is required for that study. They will be directed to submit the necessary documents via email to ORC_ICF_Review@rush.edu. Materials reviewed include:
Copy of the executed Informed Consent Form (ICF)
Copy of the documentation of the Informed Consent Process (signed and dated by the individual obtaining consent)
Copy of the Subject’s Demographics Page (if not registered in EPIC)
Copy of the executed Assent Form (when applicable)
Copy of the executed Short Form (when applicable)
Copy of the executed HIPAA Authorization (when applicable)
Questions about the SOP or process for complying can be directed to:
Learners can self-enroll or, in some cases, the ORC is able to assign these modules to employees and/or to those who have exhibited a need for further education post EQuIP audit.
Suggested REDCap Language for Publications
Date Issued: January 1, 2021
REDCap requests that the following language be used in publications that used REDCap for data collection and management:
Study data were collected and managed using REDCap electronic data capture tools hosted at Rush University Medical Center.1,2 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.
1PA Harris, R Taylor, R Thielke, J Payne, N Gonzalez, JG. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.
2PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]
REDCap
REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline electronic data capture for research studies and operations.
Rush REDCap by default will allow any Rush employee with a valid Rush user name and password to login into REDCap here.
If you don’t currently have a Rush account or you are not a Rush employee then you will not be able to login to Rush REDCap. Please perform the following steps to request an external/collaborator REDCap account:
Once a user completes the form above, the PI/Sponsor will receive an email notification requesting the PI/sponsor to authorize the user for a new REDCap account.
Rush IS will create a new REDCap account and send the account information to the user.
Note: The PI/Sponsor is responsible for sharing the external/collaborator REDCap account request above to the external/collaborator.
Quick Reference Guide for Clinical Trial Agreements
Hello Research Community!
The following can now be found under the “Grants and Contracts” Section to the left, as well as two available CDA forms. To help you through the Clinical Trials contracting process, here is the content.
Institution’s Legal Name: Rush University Medical Center (“RUMC”) (includes the University, RUMG, ROPH, and all subsidiaries)
Institution’s Address: 1653 West Congress Parkway, Chicago, IL 60612
Parties to the Agreement: RUMC and Sponsor
The Principal Investigator is not a party to the Agreement, but will sign the agreement to document that they have read and acknowledged the agreement.
