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.
OnCore will be upgraded to version 2020R3 on Friday April 9th, 2021 at 4:00pm CST.
IMPORTANT – WHAT TO EXPECT?
OnCore will be unavailable from 4pm until notified on Friday night. Please make sure your studies/subjects are updated before 4pm
OnCore will have a new URL address (Oncore.rush.edu will no longer be available after April 9th)
An activation link/token will be sent to your Rush email to log into the new OnCore system (via Rush authentication) with the associated new link. Link will expire after 5 days.
New ICF Upload Process – Directly in OnCore!
Based on your feedback, Informed Consent Forms can be directly uploaded into OnCore effective Monday, April 12thfor studies with a Coverage Analysis. This new process will eliminate the need to upload the physical ICF document into REDCap for studies with a Coverage Analysis. You are now able to document the consent date and upload the ICF all within the Subject Console in OnCore! Note: REDCap e-Consent will still be tracked in REDCap, and you will not be required to upload your form in OnCore if using e-Consent.
The OnCore Team will be providing open office hours this week to answer any ICF upload process questions.
Participation – Registration for these sessions is not required; however, you will be asked to sign an attendance sheet
Additional Resources – If you are unable to attend the Office Hours, an OnCore job aid and webinar – Uploading the CRB Informed Consent Form (ICF) in OnCore – will be available on the Rush Research Portal (RRP > Home > Clinical Research Administration > OnCore System News & Information > Subject Management Training)
For more information regarding the OnCore Upgrade and New ICF Upload Process, please contact Nisha Pillay.
Revised Short Form Consents Now Available!
Date Issued: March 24, 2021
The English Short Form Consent has been updated and now includes all required HIPAA language. The updated document also includes fillable form functionality. The English version has been translated into fifteen other languages and those versions are available as well. When this updated version is used, no additional HIPAA form is required.
For more information regarding the use of these documents, please contact John Cobb.
Clinical Research New Hire Education Requirements
Date Issued: March 23, 2021
All newly hired Clinical Research Coordinators, Clinical Research Regulatory Coordinators, and Clinical Research Nurses need to attend the new hire education course “Foundations of Clinical Research” as part of their onboarding.
The course is comprised of six modules and currently being offered bimonthly via Webex. Newly hired clinical research personnel can search the course catalog for “Foundations of Clinical Research” and self-register via the Rush Learning Hub. Newly hired personnel should enroll in the next available “Live” option of the course. A competency evaluation will be required following course completion.
On-demand, pre-recorded presentations of each module can also be found in the Rush Learning Hub and are available for all research staff.
For more information regarding clinical research new hire education requirements, please contact Kelli Jones.
Research Volunteers Onboarding Process
Date Issued: March 17, 2021
All research volunteers need to be onboarded through the Office of Volunteer Services. To begin the onboarding process for your volunteer, please complete the following information and send to Thelma Eloby. The onboarding process (including application, training modules and health clearance) will take between 5-7 days.
Once all the requirements have been met, an ID badge will be issued. For additional information please do not hesitate to contact the Office of Volunteer Services at 312-563-3652.
For more information regarding the research volunteers onboarding process, please contact Kristin Moody.
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.
LabArchives Electronic Laboratory Notebooks
Date Issued: March 8, 2021
LabArchives is a secure, cloud-based Electronic Laboratory Notebook (ELN) that offers Rush PIs, lab managers and other lab personnel a secure means to organize, document, store, protect, collaborate, and share research and data. Rush has licensed LabArchives to help researchers improve the quality of their lab notes. This resource is available at no cost to the Research Community. For more information, please go to: https://www.rushu.rush.edu/research/electronic-research-notebook.
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.
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 (email@example.com) with additional questions about this resource.
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:
Occasionally, during the synchronization process, changes to the Costs and Research- Related Injury sections of the consent document are required in order to ensure that the study’s contract is in agreement with the information provided in the consent document. These changes are facilitated via Amendment for review and approval by the IRB. We ask that you now include a copy of the correspondence (the document that specifies the changes that need to be made) that you receive from the Sync Specialist in your Amendment. The inclusion of this document is a quality assurance measure that ensures that the IRB has the necessary documents to complete their review.
We will continue to use our normal channels of communication (Research Administrator’s Forum, Rush Research Portal Home Page, and Rush research list- servs) to educate our research community on these topics. We will also plan for other opportunities to discuss as needed.
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.