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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‚Äčolic‚Äčies 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:

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.

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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