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!
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
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.
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:
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:
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.