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BROWSE



  01. Getting Started   02. Training & Education   03. Basic & Translational
Research   04. Clinical Research   06. Conflict of Interest   07. Contract
Templates   08. COVID-19   09. Electronic Informed Consent   11. Grants   13.
Institutional Review Board   14. Laboratory Safety   17. Policies & Procedures  
18. REDCap   20. Research Applications & Systems   23. Safety & Ancillary
Committees   24. Stay Connected   25. Contact Information   10. Forms and
Documents   05. Clinical Research Administration


 


BASIC FOLDER INFORMATION


HOME


 

Process to request “Activation of Inactive MRN” has Changed! 

Date Issued: December 13, 2022

What is an Inactive MRN: When an MRN is available in EPIC but is not pulling
into OnCore. Impact: Study team cannot enter the consented subject onto the
study in OnCore. New MRN activation requisition process: Study team can directly
open the ticket in EPIC Hyperspace.  A stepwise process to open an EPIC
hyperspace ticket is available in the Research Administrative Forum (RAF) slide
deck for December 2022. This is posted in the Rush Research Portal as follows:
Rush Research Portal Home Page -> Stay connected -> Research Administrative
Forum documents and slides -> RAF 2022 -> 12/9/2022.

Please reach out to Priya Mishra, Priya_mishra@rush.edu with any additional
questions or if you need help with opening EPIC Hyperspace ticket. 
 

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. 
 
Training sessions are listed in the Rush Research Calendar. For additional
information and specific registration information, contact Colleen Sowinski.
 

Documenting Invoiceable AEs and SAEs in OnCore 

Date Issued: August 10, 2022

Effective August 15, 2022, the Office of Research Affairs and Revenue Cycle will
introduce a required workflow for all departments, that will allow study teams
to document invoiceable Adverse Events (AEs) and Serious Adverse Events (SAEs)
directly in OnCore. This new process was created to ensure all contractually
approved invoiceable medical occurrences are properly and efficiently tracked,
billed, and invoiced.

Training on this new workflow can be found by self-registering for the new
“OnCore 301: Documenting Invoiceable AEs and SAEs in OnCore” course within the
Rush Learning Hub. After logging into the Hub, click “Course Library”, filter by
“OnCore 301” and if prompted, select all Statuses and Course Types. Click
“Apply”. This eLearning is “on-demand” so participants may self-register.

Please email OnCore_Team@rush.edu with questions.
 

Rush’s Annual Conflicts of Interest (COI) Survey Launches the Week of July 11 

Date Issued: June 6, 2022

Rush, including Rush University, is an institution of public trust. In
recognition of that status, all Rush employees, faculty, staff and students are
expected to conduct their affairs in ways that exemplify the Rush mission and
ICARE values. Annual reporting of outside professional activities through the
conflicts of interest (COI) survey process helps safeguard the work and
reputations of Rush employees, faculty and staff and underscores excellence in
what we do.

Rush's COI policies are designed to ensure that individuals disclose these
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.

Based on your role at Rush, you may receive an email with survey instructions
the week of July 11. The completion deadline is July 29. If you do not receive
the survey, you are still required to report any relationships or activities
described in the conflicts of interest policy and/or vendor guidelines to your
supervisor and the COI Office. To read the full policy, visit the p olic ies and
procedures page on Inside Rush and search for Policies OP-0359 and CC-RC-0008
(research). COI guidelines for working with vendors are available here. 

The timeline below outlines key dates you should be aware of.

 * COI Survey Launch: Week of July 11
 * COI Survey Completion Deadline: July 29, 2022
    
 * COI Survey Launch to Residents: August 1, 2022
 * COI Survey Completion Deadline for Residents: August 29, 2022
    
 * Referral to Supervisors for non-completion: August 29, 2022
 * Sanctions imposed: September 19, 2022
    

For Answers to Frequently Asked Questions on the COI policy and Vendor
Guidelines, click here.

For questions that are general COI related, please call (312) 942-5303 or email
COI_Office@rush.edu.

For technical COI survey questions and help, send an email to
COI_TechnicalSupport@rush.edu.
 

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
 

OnCore 101 has Changed!

Date Issued: February 10, 2022

OnCore 101 has transitioned to an on-demand, eLearning Program called “OnCore
101:  Learning Program”.

The content covered in “OnCore 101: Learning Program” is the same as what was
previously taught in the former, instructor- led OnCore 101 course. It
introduces suggested tips for navigating within OnCore and information study
teams will need to manage their clinical research studies and track their
subjects. 

This new format is self-paced and allows learners to more easily complete the
program around their personal/ departmental onboarding and training schedules.

The OnCore 101:  Learning Program includes three (3) mandatory courses:  OnCore
101:  Webinar “Before Taking OnCore 101”, OnCore 100:  Navigation and OnCore
101.  The OnCore 101 Course now includes a mandatory evaluation that must be
completed and passed in order to receive learner credit.

The OnCore 101: Learning Program is

 * the pre-requisite for all other OnCore classes
 * a training requirement for all research staff involved in human subjects’
   research studies that will manage data in OnCore, Rush’s Clinical Trial
   Management System (CTMS)
 * required in order to gain access to OnCore
 * a permanent replacement for the former instructor-led Oncore 101 course

To begin self-registration in the Rush Learning Hub, enter OnCore in the search
bar (upper right) and the eLearning program should appear.  Click Register.  You
will receive access to OnCore within 48 hours upon successful completion of the
learning program.

If you are a contracted employee, temporary employee or volunteer and do not
have access to the Learning Hub, please email OnCore_Team@rush.edu.

A complete catalog of OnCore courses and program offerings can be found here.

Please email OnCore_Team@rush.edu with additional questions regarding the OnCore
101:  Learning Program.
 


My Console: Effectively Managing Subject Visits in OnCore

Date Issued: December 9, 2021

The My Console:  Effectively Managing Subject Visits in OnCore eLearning module
is now available on the Rush Learning Hub. 

The eLearning module introduces the My Console feature in OnCore which provides
information needed to assist study teams in managing subject visits across all
assigned protocols.

When accessing My Console, study teams can view assigned protocols, subjects,
and subject visits without launching the CRA and/or Subject Consoles.  Occurred
(Submitted and Monitored) and Pending Visits can also be updated while in My
Console.

Lastly, this eLearning module provides direction on uploading the Monitoring
Letter and documenting the Protocol/Regulatory Monitoring Visit in the PC
Console of OnCore.

After accessing the Rush Learning Hub enter “My Console” in the upper right
search window, and the eLearning module should appear.

Please email OnCore_Team@rush.edu with questions regarding this Rush Learning
Hub module.


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.
 


Maestro Clinical Research Reports & Dashboard Training Webinar

Date Issued: October 7, 2021

The Maestro Clinical Research Reports & Dashboard Webinar is now available on
the Rush Learning Hub. 

On September 24, Clinical Research Personnel gained access to the Clinical
Research Dashboards and Reports in Maestro. Each research team member may now
view Study Activation, Accrual, Subject Enrollment, and Diversity data through
Maestro.

The Training Webinar will assist clinical research personnel with basics such as
how to access, launch, and sign into Maestro. This webinar also provides
departments with an overview of how to navigate to, view, and utilize specific
features of each dashboard and report.

After accessing the Rush Learning Hub, enter “Maestro” in the upper right search
window, and the webinar link should appear.

Please reach out to Kelli Jones with additional questions regarding the clinical
research reports or dashboard training webinar.
 


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!

Date Issued: August 26, 2021

The version 1.0 of updated Business and Payment terms has been posted. Located:
Rush Research Portal > Clinical Research Administration > Study Activation. We
highly recommend study teams use this tool while reviewing and negotiating
payment terms. This will help us bring standardization on RUSH accepted payment
terms standards across all RUSH divisions.

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.

 

Monitoring Informed Consent, HIPAA & Consent Documentation SOP

Date Issued: January 5, 2021

Effective February 1, 2019, the Office of Research Compliance (ORC) introduced a
new Standard Operating Procedure (SOP) titled:  Monitoring Informed Consent,
HIPAA & Consent Documentation.

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:

 Jennifer Strong, MS, CCRP.  Jennifer_A_Strong@rush.edu

Research Compliance Specialist, Office of Research Compliance

 

Informed Consent Education Sessions 2021

Date Issued: January 5, 2021

What: Rotating WebEx sessions to discuss all aspects of the informed consent
process for research participants

When: 2nd Thursday of every month

Time: 12 noon to 1 p.m.

When and where:

 * 2/11/21, 5/13/21, 8/12/21, 11/11/21– Regulatory Implications of ICF 
   https://rush.webex.com/meet/colleen_s_sowinski
 * 3/11/21, 6/10/21, 9/9/21, 12/9/21– Informed Consent and Process Note 
   https://rush.webex.com/meet/jennifer_strong
 * 4/8/21, 7/8/21, 10/14/21– Assents and Short Forms 
   https://rush.webex.com/meet/jennifer_strong

Bring ANY questions, concerns, thoughts, ideas, forms, (ICF related) you would
like to discuss.

 

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.

 


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.

Notice:

 

 

Vice Provost for Research

Rush University Medical Center

Office of Research Affairs

1653 West Congress Parkway

Chicago, IL 60612

Fax: (312) 942-2874

 

With a copy to:

General Counsel

Rush University Medical Center

Office of Legal Affairs

1700 West Van Buren Street, Suite 301

Chicago, IL 60612

Fax: (312) 942-4233

 

 

 


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