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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.

 

List of Commonly Used Clinical Research Acronyms Available!

Date Issued: July 29, 2021

A list of Commonly Used Rush Clinical Research Acronyms is now available. This list was compiled after being specially requested by some of our newly hired clinical research staff attending the “Foundations of Clinical Research” course. Clinical Research Personnel can access the list via the “Study Activation” folder of the Clinical Research Administration section.

Please reach out to Kelli Jones with additional questions about this document.

 

Mandatory Annual Conflict of Interest Survey

Date Issued: June 28, 2021

Rush’s annual Conflict of Interest (COI) survey launches the week of July 12th

Rush University Medical Center, including Rush University, is an institution of public trust.  In recognition of that status, all Rush employees, faculty and staff are expected to conduct their affairs in ways that exemplify the Rush mission and ICARE values.  Annual reporting on outside professional activities through the COI survey process helps safeguard the work and reputations of Rush employees, faculty and staff.

Rush COI policies are designed to ensure that individuals disclose these relationships, and 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.

Rush’s annual COI survey launches the week of July 12th.  Based on your role at Rush, you may receive an email with survey instructions from the Rush Portal.  Those not receiving the survey by email are still required to report any relationships or activities described in the policy and/or vendor guidelines to their supervisor and the COI Office if such a relationship exists.  The timeline below outlines key dates you should be aware of.

  • Week of July 12th – COI Survey Launch  /  July 30th – Survey Completion Deadline & Reminder
  • August 2nd – COI Survey Launched to Residents and Board Members  /  August 20th – Survey Completion Deadline & Reminder
  • August 30th – Referral to Supervisors for non-completion   /  September 7th – Sanctions imposed

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

For General COI related questions, please call (312) 942-5303 and press option 2 or send an email to COI_Office@rush.edu

For technical COI survey issues, please send an email to COI_TechnicalSupport@rush.edu or call the Help Desk (312) 942-4357 for assistance.

 

Subject Enrollment Standard Work Announcement

Date Issued: April 9, 2021

As you are aware, the Rush Subject Enrollment Policy OP-661 indicates that, for those studies requiring a full coverage analysis, each individual subject must be registered in the CTMS (OnCore) within 24 hours of consent and have their informed consent form uploaded to REDCap within 24 hours of consent.

A group of Research Administrators, Clinical Research Coordinators, and other subject matter experts recently participated in an improvement event designed to standardize and improve the subject enrollment process. Over the course of the past month, this group has developed and experimented with a series of tools and job aids that we have packaged for your use and access. This Subject Enrollment Standard Work Package consists of the following:

• Research Administrator Subject Enrollment Standard Work 
• Clinical Research Coordinator Subject Enrollment Standard Work
• Research Administrators – Key Reports in OnCore
• Clinical Research Coordinators – Key Reports in OnCore
• How to View Informed Consent Forms in REDCap - Research Administrators
• Virtual Daily Huddle / MS Teams
• Subject Enrollment - Key Resources
• Subject Management Trainings - Pre-Requisites

The purpose of this Subject Enrollment Standard Work Package is to highlight the best and most waste-free way of enrolling research subjects that we currently know and to encourage a more standard approach to subject enrollment activities. We hope that these resources will allow you and your teams to employ creative solutions developed and validated by a group of your own colleagues. We recommend that each department follow the standard work outlined above and use the tools developed to help promote adherence to the Subject Enrollment Policy.

Please reach out to Crista Brawley (crista_brawley@rush.edu) with additional questions about this policy.

 

The Study Activation Toolkit is Now Available!

Date Issued: March 15, 2021

The Study Activation Toolkit contains tools for navigating the industry sponsored, clinical research billing study start up process. These tools were built following the development of the Study Activation Playbook in collaboration with process owners and other key stakeholders as part of a Study Activation Improvement Event. Within the toolkit, you will find the following resources:

  • Study Activation Portfolio Management Package:
    • Step 1: Study Activation Reports in OnCore Guide
    • Step 2: Visual Study Start Up Tracker Template (with video demo)
    • Step 3: Clinical Trials Study Activation Multidisciplinary Team Meeting Charter
  • Tool: Study Activation Quick Card
  • Tool: Standard Business Terms / Payment Terms Guidance Document

We hope you find these new resources helpful. Please reach out to Jackie Rollin with additional questions about these tools.

 

Federal Conflict of Interest (FCOI) Training for Federally Funded Researchers

Date Issued: January 28, 2021

A Rush specific tutorial has been created that covers Rush policy on Conflict of Interest (COI) and federal requirements on FCOI at 42 CFR Part 50 Subpart F, Promoting Objectivity in Research. This training is now offered through the new Rush Learning Hub, effective January 2021.

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

FCOI-Promoting Objectivity

Researchers may also filter by course name in the Course Library at learninghub.rush.edu

It is important to store your training completion date for future reference and to provide proof of completion to the Rush Sponsored Program Administration (SPA) Office and COI Office.

 

The Study Activation Playbook is Now Available!

Date Issued: January 12, 2021

The Study Activation Playbook is a guide for navigating the study start up process for industry sponsored, clinical research billing (CRB) studies at Rush. Each chapter represents the standard work (including process steps and timeframes) involved in each aspect of the study activation process. This document was created in direct collaboration with process owners and other key stakeholders as part of a Study Activation Improvement Event. Section headers indicate the owners / approvers for each standard work chapter, as well as the date of last update. This playbook will be updated and augmented as necessary. Playbook chapters include:

  • Chapter 1: Coverage Analysis
  • Chapter 2: IRB
  • Chapter 3: Budget Negotiations
  • Chapter 4: Contract Submission to Execution
  • Chapter 5: Financial Review Signoff
  • Chapter 6: ORA Sync
  • Chapter 7: Revenue Cycle Sync
  • Chapter 8: Calendar Release

We hope you make use of this new resource. Please reach out to Jackie Rollin (jacqueline_rollin@rush.edu) with additional questions about this resource.

 

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]

 

For questions, please contact:

Crista Brawley, PhD, CCRP

AVP, Res Reg Ops

crista_brawley@rush.edu
312-942-7276

 

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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