The Rush consent/authorization template has been updated (Version 03/2025) to include the following changes. The updated template along with the Summary of Changes is now live on the portal Home page (Institutional Review Board -> Forms and Templates -> under Consent Forms) and Section 15.2 (Consent Forms and Process of Consent) of the IRB application. Please use the new template for all new studies that are submitted to the IRB after 03/20/2025.
Added optional language for studies using rideshare/transportation services (e.g., Lyft Concierge, Uber Health, Kaizen Health)
Added optional language for studies using the Advarra Participant Payment System to compensate participants
HIPAA section: Added optional language for studies using rideshare/transportation services
Under Certificate of Confidentiality, added a reference to the new IRB guidance document
Costs section: Revised to include only two options: one for minimal risk studies and one for greater than minimal risk studies
IRB contact information section: IRB Administration’s general email address was added.
If you have questions regarding these changes, please email IRB_Team@rush.edu.
Updated Clinical Research Frequently Asked Questions
Date Issued: March 21, 2025
Effective March 21, 2025, an updated Clinical Research Frequently Asked Questions (FAQ), version 7.0, is available. This document can be found in the Clinical Research Folder of the RRP under "Helpful Resources".
The updates to the document include:
Updated legal contact for contracts.
Updated Research Administrations Shared Services (RASS) contacts.
Updated Epic CareLink (used for study monitor Epic access) legal contact information.
For further questions, please contact Corey Woods.
IRB Administration Updates
Date Issued: February 26, 2025
ANNUAL CHECK-IN REPORT
In an effort to maintain oversight over ongoing exempt and expedited research that does not require continuing review, the RUSH IRB will now require submission of an Annual Check-In Report (ACR). Over the past few months, IRB Administration has collaborated with our Information Services (IS) team to build out the ACR form and activities in the portal, which will go live after the 02/28/2025 portal patch.
For Existing Studies
Notices informing study teams that the ACR is due will be sent via the portal in batches on a quarterly basis for calendar year 2025 on March 15th, May 1st, August 1st and October 1st
A pre-determined due date will be used to send the notices and reminders via the portal
Study teams will have 60 days from the date of the first notice to submit the ACR
The portal will send four additional reminders to study teams at 45, 30, 10 and 0 days before the pre-determined due date
ACR approval will grant the study another year of approval
ACRs will be required until the study team submits for closure or completion in the portal
Failure to submit the ACR within the allotted time will result in administrative closure of the study without further notification and a new IRB application will need to be submitted to continue the research
For New Studies (Initial Reviews)
New exempt and expedited studies that do not require continuing review that are approved after the 02/28/2025 implementation date will now have an Annual Check-In Report Due Date listed in the approval/acknowledgment letter. This date will also be posted in the IRB Summary Workspace as well as any amendment approval letters to remind study teams of the due date
The Annual Check-In Report Due Date will be one year from the date of Initial Review approval
Study teams will receive reminders to submit the ACR at 60, 45, 30, 10 and 0 days before the due date
Failure to submit the ACR will result in administrative closure of the study without further notification and a new IRB application will need to be submitted to continue the research
If you have questions regarding these changes, please email IRB_Team@rush.edu.
Epic Research Refuel LIVE!
Date Issued: January 13, 2025
The Epic Research Refuel updates are LIVE! These updates will expand and enhance Epic functionalities supporting research activities.
While the refuel will optimize Epic to better support our Rush investigators and research staff, it will also bring upgrades to help all clinicians identify research related activities as well as make greater information available to patients who are subjects in research studies.
Based on training completed, research user templates (access and permissions) have been updated to align with new functionality and appropriate controls based on job titles/roles.
Please visit the ORA – Epic & Research Microsoft Teams site for the latest information as well as details about training, especially if you have outstanding requirements. For access to the MS Teams site, questions, or concerns, please contact ORA_Epic@rush.edu.
Support for week of January 13th:
Major issues should get a ticket: Please visit help.rush.edu or call 2-HELP at RUMC, 6-5000 at ROPH, and 630-978-4968 at RCMC
Under ORA Industry relationship project, ORA is excited to announce the successful establishment of Rate Card on key non-procedural, protocol-related charges with industry sponsor, Merck. The “Merck Study Rate Card” can be used by all study teams at RUSH conducting clinical research sponsored and/or funded by Merck.
Study teams can utilize the rates featured on the Merck Study Rate Card for any Merck funded study currently in start-up and for all upcoming future Merck trials up until November 18th, 2026. Rate Card line items can be used directly into the study budget by the study team which helps with speedy budget negotiation.
Please contact Priya_Mishra@rush.edu with further questions regarding this document or its use.
Updated Clinical Research Frequently Asked Questions
Date Issued: November 11, 2024
Effective November 11, 2024, an updated Clinical Research Frequently Asked Questions (FAQ), version 6.0, is available. This document can be found in the Clinical Research Folder of the RRP under "Helpful Resources".
The updates to the document include:
Updated required training for newly hired clinical research staff.
Added information on the Research Onboarding Learning program (ROLP).
Updated CITI training contact information.
Added information about the Innovation and Technology Management Office (ITMO).
Added information on where to find the IRB’s ICG GCP statement.
Updated private practice (ophthalmology, anesthesia, Pain Center, SurgiCenter) service set-up information.
Updated ECG locations.
Updated subject transportation options.
Updated consent translation information.
Updated Epic CareLink legal contact information.
Updated subject stipend/reimbursement options.
Added computer hardware destruction information.
Updated FDA audit contacts.
For further questions, please contact Corey Woods.
Important Epic Beaker/Rush Medical Laboratories Update
Date Issued: October 18, 2024
As shared in the recent email from Dr. Casey on 10/15/24, the RUSH Lab Information System (LIS) is transitioning to the Epic Beaker Lab Information System. For researchers, this new functionality includes Computerized Provider Order Entry (CPOE) for research staff which will go-live on 10/19/24.
After this date, all research/sponsor paid Rush Medical Laboratories (RML) lab testing that previously used paper requisitions will require Epic order entry. Moving forward, research paper requisitions will no longer be created or used. Electronic order entry increases visibility, efficiency and accountability for all those involved in the subject’s care – study team, lab team and clinical team.
As shared in numerous venues over the last few months, it is important to recognize that study teams (including study coordinators) will now be responsible for Epic order entry. Additionally, all lab orders entered by non-clinician study coordinators will require a “second sign” by a clinician before the order can be executed. The only exception is when solely a venipuncture is needed from RML. The Office of Research Affairs (ORA) has worked to identify and schedule training for research staff that will be utilizing this new functionality. Training should be completed immediately so permissions and access can be updated to allow order entry. All the steps to ensure appropriate training and access has been provided on the "ORA--Epic & Research" Microsoft Teams Site.
Throughout this exciting transition please feel free to reach out to ORA_Epic@rush.edu.
NEW: AbbVie Study Rate Card
Date Issued: October 14, 2024
Under ORA Industry relationship project, ORA is excited to announce the successful establishment of Rate Card on key non-procedural, protocol-related charges with industry sponsor, AbbVie. The “AbbVie Study Rate Card” can be used by all study teams at RUSH conducting clinical research sponsored and/or funded by AbbVie.
Study teams can utilize the rates featured on the AbbVie Study Rate Card for any AbbVie funded study utilizing AbbVie Master Clinical trial agreement currently in start-up and for all upcoming future AbbVie trials up until June 30, 2026. The fees associated with line items included in the rate card will be re-evaluated for FY2027. Rate Card line items can be used directly into the study budget by the study team which helps with speedy budget negotiation.
The AbbVie Study Rate Card is now available on the portal under Clinical Research > Study Activation > Study Budgeting > Rate Card
Please contact Priya_Mishra@rush.edu with further questions regarding this document or its use.
RUSH Onboarding Learning Program (ROLP)
Date Issued: September 20, 2024
Effective September 20, 2024, The Office of Research Affairs (ORA) and the Office of Research Compliance (ORC) are pleased to announce the launch of the new Research Onboarding Learning Program (ROLP), which includes nine eLearning courses bundled together into one learning program.
The ROLP has replaced the instructor-led course, “Research Compliance Onboarding and RUSH Research Portal Training”, offered weekly via TEAMs. Users can now self-register for the ROLP within the RUSH Learning Hub.
By providing the ROLP asynchronously as an eLearning program, participants can 1) complete the training at their convenience, 2) proceed at their own pace, 3) practice what they have learned through simulation-based learning and knowledge checks, and 4) access a point of reference for questions that arise after training is completed.
Completion of the ROLP is a requirement for access to the RUSH Research Portal per the Education Policy for Investigators and Relevant Research Personnel. Users who complete the entire nine-course Learning Program will receive an email containing a REDCap (Research Electronic Data Capture) form to request an RRP account. Check out the new RRP One Pager for additional details.
If you have questions about the ROLP, please email RRP_Team@rush.edu.
If you have questions about maintaining compliance in your research practice, please email Tiffany_Bailey@rush.edu
If you do not have an active RRP account, you can access this information on the Getting Started folder in the RRP.
NEW: RUSH Clinical Research Justification Letters- Department Annual Maintenance Fee, Study Closeout Fee, and Archiving/ Record Retention Fee
Date Issued: September 11, 2024
The Department Annual Maintenance Fee, Study Closeout Fee, and Archiving/ Record Retention Fee justification letters provides details on the key tasks required to be performed during Conduct phase, Closeout phase, and after study is IRB closed at RUSH respectively, and serve as a justification for the fee amounts requested.
These justification documents come in handy and facilitate the budget negotiation process. Study teams should provide these documents to external sponsors/funders when negotiating their budgets during study start-up.
Please contact Priya Mishra with further questions regarding these documents or its use.
Epic Research Refuel Project Update
Date Issued: August 28, 2024
The Epic Research Refuel project launched in May 2024 and has made significant progress over the summer. This project has two main portions: (1) research conduct and (2) research billing, with go-live planned for January 2025. Additionally, the organization-wide Epic Beaker project, which will enhance laboratory operations and modify order processes for research labs and pathology requests, is set to go live in late October 2024.
The Epic Research Refuel project presents a key opportunity to optimize RUSH’s use of Epic for research conduct and OnCore for study management. These enhancements will better support RUSH research efforts, allowing us to focus on efficiency and growth. For additional information about this project, please reference this slide deck. This document and other helpful resources will be posted here on the RRP in the Research Applications & Systems -> Epic folder. Also, to stay up-to-date on the latest trainings and resources, please visit the ORA--Epic & Research Microsoft Teams Site.
In February 2024, we announced updates to our short form consent process and policy (RA-IRB-202 Enrollment of Subjects Who Do Not Read, Speak, or Understand Written or Spoken English), which included a limit on the number of times the short form consent process can be used (two subjects, per language, per study). To track the enrollment of limited English proficient (LEP) subjects, we have updated our Amendment and Continuing Review forms to include the following new questions. Please note that if your amendment or Continuing Review was submitted before 08/02/2024, the submission will be returned to you with a request to complete the new questions.
Amendment Form
Item #2.1 captures the expected date of use for an amendment that includes a request to use a short form consent to enroll a specific LEP subject.
Item #4.1 asks if any LEP subjects have been enrolled in the study.
If LEP subjects have been enrolled, item #4.1.1 asks what type of consent document was used to enroll them.
If the short form consent was used, item #4.1.2 asks for the number of subjects that have been enrolled in each language and the date of enrollment for each LEP subject.
Continuing Review Form (under “Subject Enrollment Information v2”):
Item #11.0 asks if any LEP subjects have been enrolled in the study.
If LEP subjects have been enrolled, item #11.1 asks what type of consent document was used to enroll them.
If the short form consent was used, item #11.2 asks for the number of subjects that have been enrolled in each language and the date of enrollment for each LEP subject.
IRB APPLICATION UPDATES
The device sections of the IRB application have been updated to be more inclusive of the different device types that can be used in research. We also added information to remind study teams of their responsibilities when sharing and receiving data or biospecimens involving an external entity.
Section 7.3 (Use of Medical Devices v2):
Item #1.2 was revised to include a note to clarify that the study team should submit FDA documentation that discloses the status of the device that is used in the research but is not under an IDE.
If the device used in the research is not under an IDE, then the study team should identify the device type (e.g., HUD or 510k) under item #1.3, which was added.
Item #4.0 was revised to include additional examples of documents that can be submitted for a device other than a device brochure (e.g., Instructions for Use, IFU).
Section 7.3.1 (Medical Devices - Risks and Side Effects):
Devices that are not under an IDE may not have a significant risk (SR) or non-significant risk (NSR) determination from the FDA. Therefore, item #1.0 was revised to add an “Other” option to cover such devices.
Item #1.1 was added to allow study teams to explain why the FDA did not make a risk determination for the device used in the study.
Section 16.0 (Data Privacy & Confidentiality)
Help text was added at the top of this section that describes the types of agreements that must be used when sharing and receiving data or biospecimens involving an external entity as well as descriptions of the Safe Harbor de-identification process and limited data sets.
If you have questions regarding these changes, please email IRB_Team@rush.edu.
REMINDER: Upcoming Democratic National Convention
Date Issued: August 5, 2024
The Democratic National Convention (DNC) will be held at McCormick Place and the United Center in Chicago from Aug. 19 – 22. Due to the close proximity of Rush University Medical Center to the United Center, there is an anticipated impact on medical center operations from Aug. 15 – 24.
The Office of Research Affairs (ORA) is recommending study teams minimize the number of individuals (both study personnel and study participants) on-site during this time. Travel to and from the medical center is expected to be difficult due to increased security, possible road closures, and potential demonstrations.
From Aug. 15 – 24
Research staff should work remotely, whenever possible, to limit traffic to and from campus.
On-site monitoring visits should not be scheduled during this time. Memo issued by ORA and available in the Clinical Research Folder of the RRP under “Helpful Resources”.
Community oriented research work should carefully consider the convention impact area and consider adjusting schedules accordingly.
Carefully consider starting any experiments that could be impacted by limitations getting to campus.
During the convention from August 19-22
If clinically reasonable, research subject visits should be rescheduled. DNC related patient-subject travel preference and staff work schedule impacts, are a reasonable explanation for protocol deviations during this time period. Please note, many ambulatory clinics are modifying their schedules. Ensure awareness of those schedules if planning for any in person clinical research activities.
Contact your department leadership regarding specific preparations and guidance.
If you must come to campus, allow extra time to get here, be sure you know whether your parking options are changing, and be patient.
This website includes a number of relevant updates about DNC preparations and will be updated on a regular basis. We recommend checking it often. Additionally, it is recommended that all employees sign up for RU Alerts.
Advarra Participant Payments System (PPS)
Date Issued: August 5, 2024
Effective August 5, 2024, the RUSH Office of Research Affairs (ORA) is offering Participant Payments System (PPS) to all study teams. PPS is an automated payment system from Advarra that allows study teams to efficiently manage payments made to study participants, including stipends and reimbursements.
PPS can be integrated with OnCore, RUSH’s clinical trial management system (CTMS), allowing for even more study team visibility and oversight of subject payments.
Study teams are encouraged to consider using PPS for any study issuing payments to research participants. The ORA conducted a pilot trial of PPS throughout FY24 and found that using PPS 1) aided in participant retention, 2) reduced administrative burden and costs for RUSH, 3) boosted efficiency of the process from study team request to participant payment receipt and 4) improved the overall research participant payments process for staff and participants alike.
To learn more about Advarra PPS, navigate to the Participant Payments System (PPS) folder and read through two newly created documents, PPS Getting Started and PPS Study Team FAQs. These resources will help study teams determine whether PPS would be a good fit for their study.
For questions about PPS access or functionality, please email the ORA PPS Administrators, David DaSilva and Priya Mishra.
Research Revenue Cycle Updates
Date Issued: July 8, 2024
Fee Schedule Updates
The updated FY25 fee schedule is now posted. If the item you need is not on the schedule, please reach out to our team at research_billing_revenue_cycle@rush.edu.
Accounting and Payment Information Have Changed
The payment address and account information are changing July 1, 2024! Updated information can be found under the CTA Business and Payment Terms Document in the portal under study activation.
What does this mean for me?
If your study is Industry or Fee for Service Subaward, Sponsor Invocing (SI) requires all payment information included in the executed CTA if the trial is being invoiced by our team. New information is available on the portal and will need to be included in all newly submitted industry sponsored trials beginning July 1, 2024. Any trial that is “in the study activation pipeline” as of June 30, 2024, that does not have an executable CTA, will need the payment information updated PRIOR to contract execution.
If there is an amendment in process as of June 30, 2024, please reach out to sponsor_invoicing@rush.edu. We will work with you to update the payment information prior to execution.
How is the current payment address and account information changed in ongoing trials?
The SI team will be submitting a Payment Intake Form (PIF) to sponsors to update current trials supported by our team. Once all the information is updated for your department, amendments will need to be submitted to update the terms later. We will contact the clinical team for more information.
If my study is closing, do I need to change the information?
This depends on the closure date of the trial. If the study is closing within the next six months, the payment address and account information will not change. If you know a study is closing soon, please reach out to sponsor_invoicing@rush.edu. We will work with your team to close the study and get the payments in time without making any changes.
If your study is “closed to accrual” in OnCore, our team will reach out for an estimated “IRB CLOSED” date.
Question #7 for CA Determination Submission Has Changed!
Question #7 has been revised to decrease confusion on the clinical and CA side. The hope is that the revision will provide clarity and a better workflow in delivering the initial coverage analysis. Please see the “updated” question below. As of July 1, 2024, all CAs will be built budget neutral unless otherwise specified in the determination questions.
Old question: Is your budget finalized? If yes, please upload the final budget into the document upload section. It will be applied to your coverage analysis (Y/N)
New Question: Would you like your final budget applied to the initial coverage analysis? (Please note all analyses are developed neutrally unless requested upon submission) Yes or No
Rush’s Annual Conflicts of Interest (COI) Survey Launches the Week of July 8
Date Issued: June 7, 2024
The RUSH Conflicts of Interest (COI) survey launches the week of July 8. The COI survey provides RUSH employees, faculty, and staff the opportunity to report outside professional activities and innovation. The survey process helps protect your work and reputation and underscores excellence in what we do. It serves as a reminder to conduct affairs in ways that exemplify the RUSH mission and ICARE values and safeguards RUSH as an institution of public trust.
RUSH's COI policies are designed to ensure that individuals disclose outside 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.
What to Expect
Beginning the week of July 8, based on your role you may receive an email with instructions to complete the COI survey. To determine if your role meets these criteria, please click here. All employees and faculty are subject to the COI policies and vendor guidelines and are still required to report any applicable relationships or activities, as outlined in the policy and/or vendor guidelines, to both your supervisor and the COI Office.
In the event that you do not receive the survey, and have something to disclose, please contact the COI Office.
Important Dates to Remember
COI Survey Launch Date
Week of July 8th
COI Survey Due Date
July 26, 2024
COI Survey Launch Date for Board Members and Residents
August 1, 2023
Guidance and tip sheets for the annual survey can be found here.
For further details, please access the PolicyTech page and search for the following policies:
Conflict of Interest and Commitment.
External Relationships and Financial Conflicts of Interest in Research
The COI guidelines for working with vendors are available here.
For technical COI survey issues, send an email to Help@rush.edu.
If you have questions about the survey's content or policy, please contact the COI Office at (312) 942-5303 or COI_Office@rush.edu.
The Democratic National Convention (DNC) will be held at McCormick Place and the United Center in Chicago, IL from August 19, 2024 – August 22, 2024. Due to the close proximity of Rush University Medical Center (RUMC) to the United Center, there is an anticipated impact on RUMC operations from August 15, 2024 – August 24, 2024.
The Office of Research Affairs (ORA) is recommending study teams minimize the number of individuals (both study personnel and study participants) on-site during this time. Travel to and from RUMC is expected to be difficult due to possible road closures, increased security, etc. The ORA suggests that from August 15, 2024 – August 24, 2024, on-site monitoring visits not be scheduled, and study subject visits should be avoided, whenever clinically reasonable.
A memo has been issued with this information and is available in the Clinical Research Folder of the RRP under “Helpful Resources”.
Please contact your department’s leadership regarding department specific preparations for the DNC.
NEW: RUSH Clinical Research Study Start-Up Fee Justification Letter
Date Issued: May 20, 2024
The Study Start-Up Fee Justification Letter is a document that contains a breakdown of RUSH’s clinical research study start-up fees for 2024.
This document also provides details surrounding the tasks completed during study start-up and justification for the amounts requested.
Study teams should provide this document to external sponsors/funders when negotiating their budgets during study start-up.
Please contact Priya Mishra with further questions regarding this document or its use.
Updates to Epic Access for Study Monitors
Date Issued: May 17, 2024
Effective May 17, 2024, the process for requesting Epic access and releasing information to study monitors has been updated. Detailed instructions can be found on the RRP under Home > Research Applications and Systems > Epic > Epic Carelink Resources.
The updates to the document include:
Monitors will be able to see the entire Epic record for patients associated with the study and chosen by the study team for the specific monitoring visit
The 2 year limit (on date of encounter) is eliminated
No more picking encounters!
IT contact updated to Hina Mujahid
Please contact Corey Woods with further questions.
Updated Clinical Research Frequently Asked Questions
Date Issued: May 17, 2024
Effective May 16, 2024, an updated Clinical Research Frequently Asked Questions (FAQ), version 5.0, is available. This document can be found in the Clinical Research Folder of the RRP under “Helpful Resources”.
The updates to the document include:
Added link and contact for the Institute for Translational Medicine (ITM) at Rush.
Added Research Administration Shared Services (RASS) information.
Updated Rush Medical Laboratory (RML) CAP and CLIA certificate contact.
Added information and a contact for The New Normal (TNN) for study advertising.
Updated Epic CareLink for study monitor information.
Added subject stipend/reimbursement information.
Please contact Corey Woods with further questions.
NEW: Novartis Study Rate Card
Date Issued: May 10, 2024
The ORA is excited to announce the successful negotiation and agreement of key non-procedural, protocol-related charges with industry sponsor, Novartis. The “Novartis Study Rate Card” can be used by all study teams at RUSH conducting clinical research sponsored and/or funded by Novartis.
Study teams can utilize the rates featured on the Novartis Study Rate Card for any Novartis-funded study currently in start-up and avoid negotiating any line items included. Line items may be plugged directly into the study budget by the study team. The Rate Card also features some pre-agreed upon payment terms that can be inserted directly into the Clinical Study/Trial Agreement (CSA/CTA).
The Novartis Study Rate Card is now available on the portal under Clinical Research > Study Activation > Study Budgeting > Rate Card
Please contact Priya Mishra with further questions regarding this document or its use.
Updated Clinical Research Frequently Asked Questions
Date Issued: March 26, 2024
Effective March 26, 2024, an updated Clinical Research Frequently Asked Questions (FAQ), version 4.0, is available. This document can be found in the Clinical Research Folder of the RRP under "Helpful Resources".
The updates to the document include:
Updated CITI and Office of Research Compliance (ORC) training contact.
Added Institute for Translational Medicine (ITM) information and contact.
Added information on who to contact to obtain Qualified Bilingual Staff (QBS) designation.
Added Association of Clinical Research Professionals (ACRP) information.
An updated How to Read the Research Fee Schedule has been uploaded as well.
For general pricing questions, please contactLisa Gazick.
NEW! ORA SOPs are now available!
Date Issued: February 21, 2024
The ORA has developed a set of template SOPs that meet the minimum expectations for the conduct of research at Rush. These SOPs are in line with federal, state, and local requirements as well as industry standards to help ensure we conduct compliant clinical research. These should be considered the minimum requirements. These SOPs can be adopted as-is or modified by departments as needed to reflect current operations. The SOPs can be found in the Rush Research Portal under Policies and Procedures> Conduct of Research> ORA SOPs. An FAQ is posted with the SOPs.
In a continued effort to increase regulatory compliance and provide useful tools that support the Rush research community in their regulatory endeavors, Rush IRB Administration is happy to announce the following:
NEW SHORT FORM CONSENT PROCESS:
Effective March 1, 2024 - The Short Form Consent has been updated to remove the HIPAA Authorization language. There is an Alteration of HIPAA Authorization Request Form that will be used to address HIPAA in this population. This Request Form will allow the required HIPAA information to be presented (the full English IRB approved consent is always used as the written summary; the consent already has the required HIPAA language embedded) to the potential subject but would not require the potential subject to provide a second signature on the short form for HIPAA information.
Notable changes include:
Amendment approval required prior to each use of the short form consent process; a completed Alteration of HIPAA Authorization Request Form will be required for each amendment.
Limit to number of times the process can be used – two participants, per language, per study.
Continuing Review Application and Amendment Application will be updated to capture Short Form use data.
INFORMATION SHEET TEMPLATE: This is a new tool that will be available for use in conjunction with research that is limited solely to surveys/questionnaires.
VERBAL CONSENT TEMPLATE:This is a new tool that will be available for use when verbal consent is being obtained. The template includes abbreviated HIPAA language that is more lay-person friendly, but still includes all HIPAA requirements and protections.
IRB Assurance, IRB Registration, and Association for the Accreditation of Human Research Protection Programs, Inc.® (AAHRPP) certification letters have been removed from the Rush Research Portal!
Information for both is publicly available. Sponsors, monitors, auditors, etc. should be referred to the sites if information is requested.
Office of Human Research Protections (OHRP) website is the source of truth for all IRB Assurance and Registration information. https://www.hhs.gov/ohrp; AAHRPP website is the source of truth for all AAHRPP accreditation information. https://www,aahrpp.org. A link to both websites will be included on the Rush Research Portal.
2024 Rush IRB roster is currently available in the RRP. This information will remain in the Portal because it is not publicly available.
For questions regarding these changes, please email IRB_Team@rush.edu.
Updated Study Activation Quick Card Now Available
Date Issued: February 8, 2024
The Study Activation Quick Card has been updated! It now reflects minor updates to the ORA Sync process and includes some adjusted visuals for easy viewing. This quick card is intended as a high-level overview of the study activation process for industry sponsored, CRB studies from time of CDA execution through calendar release. It provides a bird’s eye view of the recommended process flow and some overview of OnCore statuses. It can be found within the Study Activation folder, located within the Clinical Research folder in the Rush Research Portal. Please use and share with your teams as applicable.
There is an excessive number of REDCap external collaborator accounts without an expiration date. If you are an external collaborator REDCap user who is sponsored by a Rush Principal Investigator, please immediately work with your account sponsor to fill out the following link REDCap external collaborator account extension request form to extend your REDCap account. Expiration dates are required for all external collaborator accounts. If you do not do this, your account will be suspended on April 2024.
This notice only applies to studies that require collaboration with study staff from non-Rush institutions such as UIC, U of C, Northwestern University, etc. If you are a current Rush employee or Rush student then this notice does not apply to you or your study. If your study is conducted and managed by a current Rush employee and there is no collaboration with any other institutions, then this notice does not apply to you.
Effective January 30, 2024, a new document, Epic for Research at RUSH, is available. This document can be found in Research Applications & Systems, Epic, under Resources.
The goal of the document is to optimize how current Epic functions can be used to support day-to-day research operations and compile current tools. Brief descriptions, links to guidance documents and educational materials, research specific information, and contacts are included.
Please feel free to attend the following review sessions with any questions and/or suggestions:
Updated Clinical Research Frequently Asked Questions
Date Issued: January 30, 2024
Effective January 30, 2024, an updated Clinical Research Frequently Asked Questions (FAQ), version 3.0, is available. This document can be found in the Clinical Research Folder under “Helpful Resources”.
Updated Rush Medical Laboratories (RML) Research Project Request Form
Date Issued: January 25, 2024
Effective January 25, 2024, an updated Rush Medical Laboratories (RML) Research Project Request Form is available for use. In order to ensure RML services (drawing, processing, testing, and/or storing laboratory specimens) are charged to a study activity, the process detailed on this form must be utilized. The form can be found in the Clinical Research Folder of the RRP under “Helpful Resources”.
The updates to the Form include:
Updated email and fax for document submission (initial and amendments) to Emily_N_Szczebywlok@rush.edu and fax 312-563-3697.
Replaced Human Investigation Committee (HIC) with Institutional Review Board (IRB).
Updated information on arranging and scheduling blood collection by the inpatient phlebotomy team with phlebotomy leadership (Valencia_Sagnia@rush.edu).
Added Suite 439 Professional Building for outpatient blood collection.
Thank you for your ongoing engagement with and participation in the recent adjustments to the ORA Sync Process. To those of you who attended our Q&A sessions, thank you for your valued collaboration!
Below please find a list of previously discussed adjustments to the ORA Sync Process that are now in effect as of January 18th, 2024:
There are now transparent criteria for beginning the ORA Sync process (see Acceptance Criteria Worksheet)
Financial Review Sign Off (FRS) is now one of the criteria for beginning ORA Sync
The ORA Sync team will communicate ORA Sync findings via a standard checklist for each new study going through ORA Sync (see ORA Sync Checklist)
ORA Sync Team’s focus will now be more on harmonization of documents and accuracy of study demographics
Study demographics will be captured by the ORA Sync Specialist on a study summary Face Page posted to the ORA Sync Workspace (see Study Summary Face Page)
The documents noted above as well as other useful information regarding ORA Sync processes and services can be found in the ORA Sync folder in the Rush Research Portal (RRP).
What does this mean for me and my team?
The Study Team’s role in the ORA Sync process is largely unchanged
Please continue to complete Financial Review Signoff (FRS) promptly after delivery of Final CA to avoid delays (Financial Review Sign Off is now one of the criteria for beginning ORA Sync)
ORA Sync findings will now be communicated via a standard checklist appearing as an attachment to the activities within the RRP workspace
Study teams should review the completed checklist once received and address any item(s) marked “no”
Please continue to respond to ORA Sync findings via the “submit updates” button in the ORA Sync Workspace within the RRP
If an IRB amendment is required to address ORA Sync findings, please attach the ORA Sync Checklist to the IRB submission (the ORA Sync Checklist will take the place of the ORA Sync- generated correspondence letter)
Please continue to ensure the Master Project is completed entirely and accurately to avoid delays or questions related to study demographics
We hope these changes will help increase efficiency, promote transparency, and incorporate a more institutional perspective during study start up. We know that even small adjustments can take time to get used to so we will be there to support you with any questions or concerns along the way. If you have any questions on the above adjustments or on any of the resources provided, please reach out to Solomon Adelowo.
NEW! ClinicalTrials.gov Registration Determination Page Coming to the Master Project in the Rush Research Portal
Date Issued: January 19, 2024
To help take the guesswork out of determining whether your clinical trial requires registration on the ClinicalTrials.gov website, a ClinicalTrials.gov registration determination questions set has been added to the Rush Research Portal (RRP) Master Project.
Like other pages within the Master Project, the ClinicalTrials.gov Registration Determination Page is a smart page (it adjusts in real time based on your answers to each question). Following completion of the ClinicalTrials.gov Registration Determination Page in the Master Project, the user will be presented with a determination for whether their study requires registration on ClinicalTrials.gov. The determination will be based on how questions were answered in the Master Project. Should the study require registration, they will also receive an autogenerated email notification prompting them with further guidance and access to helpful tools and resources.
This page will go live in the RRP Master Project on January 27th, 2024.
For further details on what the new page entails, please access the following resources in the Clinicaltrials.gov folder in the RRP:
Amended Procedure Date Documentation Workflow in OnCore
Date Issued: December 7, 2023
Effective January 1, 2024, Research Revenue Cycle (RRC) will implement a change to the Subject Visit Tracking (SVT) workflow in OnCore.
Study teams will now be required to enter an associated procedure date for ALL procedures that occurred for the corresponding subject visit.
Implementing this workflow change will provide clarity for study staff and the Sponsor Invoicing and Charge Capture Teams through more descriptive documentation. This change will increase efficiency for all teams involved by 1) minimizing the time spent determining if the procedure was performed, 2) capturing accurate data for revenue collection, and finally, 3) generating precise Accounts Receivable (AR) reporting, which decreases voids and duplicate payments and charges.
NEW Epic Workflow for Resolving Inactive MRNs when Registering Subjects in OnCore
Date Issued: October 16, 2023
Effective October 13, 2023, The Office of Research Affairs (ORA) and the Epic Grand Central (EGC) Team introduced a new workflow requiring study teams to directly reactivate an inactive research patient Medical Record Number (MRN) in Epic Hyperdrive. The improved workflow removes the initial step of study teams opening a Help Desk ticket and/or possibly engaging personnel to further assist. Instead, study teams can follow the steps outlined in the Epic Newsflash. This new workflow (“Retrigger A31 for OnCore”) provides study teams with the autonomy to directly initiate the process of reactivation of an inactive MRN in Epic Hyperdrive.
What was the previous workflow and what has changed?
Prior to October 13, if study teams were unable to complete subject enrollment in OnCore due to an inactive MRN, they opened a ticket in the Epic Hyperspace. If they received an error and were unable to open a ticket, they emailed Priya_Mishra@rush.edu with the required information, and a ticket was opened on their behalf. The ORA and EGC partnered to reactivate the MRN and emailed study teams when enrollment could begin. On occasion, departments could be penalized for not adhering to The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy formerly referred to as the OP661 Policy for enrolling subjects within one (1) business day of receiving the signed Informed Consent Form. The new process allows study teams to initiate the reactivation of an inactive MRN directly in Epic Hyperdrive without assistance from the ORA and the EGC. A31 refers to the specific technical interface that connects these two systems and allows the MRN to transfer from Epic into OnCore.
For questions regarding this process or OnCore, please contact OnCore_Team@rush.edu
NEW! Changes to the Master Project and IRB Workspaces in the Rush Research Portal
Date Issued: September 15, 2023
Effective September 15, 2023, the Master Project and IRB Workspaces in the Rush Research Portal (RRP) contain NEW fields! These changes were implemented to ensure the transfer of data from the RRP into OnCore is complete and more accurate, but also to eliminate the need for duplicative and manual entries across our interfacing systems (including Vestigo).
The updates to the Master Project include:
Entering the Project Title in (potentially) two places instead of one, if your study is being “Pushed to OnCore”.
Continue entering the abbreviated title (255 characters or less) in the Project Title field, section 1.0. as you were previously.
NEW: Enter the project title as listed in the official protocol document (no abbreviations or acronyms) in the Long Title field, during the “Push to OnCore” (255 characters or more). Data entered in this field is transferred from the RRP into OnCore and from OnCore into Vestigo, Rush’s new web-based system created to manage investigational drug products used in Rush studies.
Including a Short Title for your project is now mandatory. The Short Title field has always appeared in the Master Project; however, populating this field is now mandatory and the data entered transfers directly into Epic for clinical research studies.
During the “Push to OnCore”, new Staff roles can be added. To add staff during the Push to OnCore, the staff member must have been previously added in the Master Project. If not, the staff name will not appear as an option to add. Adding staff in this section is not required; however, doing so will ensure the staff name and role are transferred directly to the Staff tab of the PC Console in OnCore.
Additional fields have been added to the Clinical Trials Information Section. If you indicate that your project is a clinical trial, additional questions will appear. Further information will be requested based on how you complete the smart form. The data will then be transferred directly to OnCore.
The updates to the IRB Workspace include:
Section 15.2 Consent Forms and Process of Consent - The Rush consent/authorization template has been updated to include a summary, instructions, descriptions, sample consent language, key definitions, and resources regarding the NIH Policy for Data Management and Sharing (DMS Policy) and how that information must be disclosed in the consent document. The DMS Policy applies to grant applications submitted to the NIH on or after January 25, 2023. The HIPAA section has also been updated to add a statement for studies where health information will not be shared with anyone outside of Rush and the Rush IRB has been removed from the list of entities that health information may be disclosed to.
Section 16.0 – Data Privacy & Confidentiality – Question 10.0 asks whether a Data Management and Sharing Plan is required by the NIH for the study. If answered in the affirmative, there is an upload button in 11.0.
Section 16.1.1 – HIPAA Forms – A new HIPAA form titled “Alteration of HIPAA Authorization in Research Request Form” was added. Also, minor edits were made to the three of the existing HIPAA forms, but nothing impacted user experience.
For further questions regarding these changes, please contact:
RRP@rush.edu for questions regarding the changes in the Rush Research Portal
OP-661 Policy: Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS)
Date Issued: September 5, 2023
The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy (former policy number OP-661) was recently updated by Corporate Compliance, effective August 17, 2023.
The purpose of The Mandatory Research Subject Enrollment in Clinical Trial Management System (CTMS) Policy is to ensure that study participants’ information and related study activities are entered into OnCore without delay so that the clinical services provided to them as part of their study or trial are billed to the correct financially responsible party as detailed in the study’s Coverage Analysis.
The updates to the policy provide clarification and reflect changes in our clinical research workflows since its initial publication. Please review the new version of the policy in PolicyTech, the policy and procedure management system used at Rush. Rush personnel can easily navigate to PolicyTech via the Inside RUSH page.
Please contact OnCore_Team@rush.edu for questions about OnCore and Priya_mishra@rush.edu for questions regarding the recent changes and overall adherence to this policy.
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:
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:
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.
