Amended Procedure Date Documentation Workflow in OnCore
Date Issued: December 7, 2023
Effective January 1, 2024, The Office of Research Affairs (ORA) and Research Revenue Cycle (RRC) will enforce an amended Subject Visit Tracking (SVT) workflow in OnCore.
Study teams will now be required to enter an associated procedure date for all procedures that occurred for the corresponding subject visit.
Implementing this workflow change will provide clarity for study staff and the Sponsor Invoicing and Charge Capture Teams through more descriptive documentation. This change will increase efficiency for all teams involved by 1) minimizing the time spent determining if the procedure was performed, 2) capturing accurate data for revenue collection, and finally, 3) generating precise Accounts Receivable (AR) reporting, which decreases voids and duplicate payments and charges.
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.
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
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.
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:
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 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: