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BASIC FOLDER INFORMATION


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Amended Procedure Date Documentation Workflow in OnCore 

Date Issued: December 7, 2023

Effective January 1, 2024, Research Revenue Cycle (RRC) will implement a change
to the 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.

Lisa Gazick or Sponsor_Invoicing@rush.edu for questions about Sponsor Invoicing

Lisa Gazick or Research_Billing_Revenue_Cycle@rush.edu for questions about
Charge Capture

OnCore_Team@rush.edu for questions about OnCore

 

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:

 1. 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.
 2. 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.
 3. 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.
 4. 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:

 1. 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.
 2. 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.
 3. 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 

OnCore_Team@rush.edu for questions about OnCore

IRB_Team@rush.edu for questions about the IRB Application
 

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.


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:
   * 30 business days prior to sponsor deadline submit advance notice to SPA
   * 10 business days prior to sponsor deadline request budget consultation in
     RRP
   * 3 business days prior to sponsor deadline issue Department Approval in RRP
 * Easy to use pre-award checklists for PIs, Grant Administrators, and
   Department Approvers
 * Detailed, chapter by chapter guidance on key aspects of the pre-award
   process:
   * Chapter 1: Notification and Intake (Grant Administrator / SPA Grant
     Specialist)      
   * Chapter 2: Finalize Research Plan and Scientific Portions (PI)
   * Chapter 3: Non-Scientific / Administrative Portions (Grant
     Administrator)        
   * 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
 

Informed Consent Form (ICF) Rush Learning Hub Training Modules

Date Issued: January 5, 2021

The Office of Research Compliance (ORC) created online training modules in
response to the needs of the research community. 

Click the link below to access the Rush Learning Hub.  Once accessed, click
“Register” and then “Launch”.  The video will be available for you to view.

 * Video Learning Module Short Form Consent Process
 * Video Learning Module ICF Regulations and Process
 * Video Learning Module Assent of Minors Process

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:

 * Fill out the account request form using the following link: REDCap Account
   Request.
 * 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.

Please visit REDCap at Rush University for REDCap Office Hours, FAQs, and more
information.


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