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Updated Charge Master (Research Fee Schedule) 

Date Issued: March 1, 2024

The updated Charge Master (Research Fee Schedule) is now loaded.

The content is available on the portal Clinical Research>Study Activation>Study Budgeting>Charge Master

An updated How to Read the Research Fee Schedule has been uploaded as well.

Email Lisa Gazick for general pricing questions. 
 

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.

Please reach out to CTO_Research@rush.edu with questions. 
 

IRB Administration Updates 

Date Issued: February 20, 2024

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.
 

REDCap External Collaborator Account Suspension Notice 

Date Issued: February 2, 2024

  • 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.
  • If you are sponsoring an external collaborator REDCap account, please request to extend the sponsored external collaborator REDCap account using the link REDCap external collaborator account extension request form.
  • 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.

Questions? Email REDCap Support
 

NEW! Epic for Research at RUSH Document 

Date Issued: January 30, 2024

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:

For further questions, please contact: Corey_J_Woods@rush.edu
 

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”.

The updates to the document include:

  1. Updated Financial Review Sign-Off (FRS) contact. Added FRS Approver Training.
  2. Updated RAB Investigational Drug Service (IDS) contact.
  3. Added Rush Imaging Research Core (RIRC) information.
  4. Updated ophthalmology contact.
  5. Added sponsor paid ECG (POB 461) information.
  6. Updated Epic MyChart information and contact.
  7. Added information on how to obtain approval from and utilize Rush Marketing.
  8. Updated Epic CareLink for monitors information.
  9. Updated Revenue Cycle contact if subject receives a bill.

For further questions, please contact: Corey_J_Woods@rush.edu
 

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:

  1. Updated email and fax for document submission (initial and amendments) to Emily_N_Szczebywlok@rush.edu and fax 312-563-3697.
  2. Replaced Human Investigation Committee (HIC) with Institutional Review Board (IRB).
  3. Updated information on arranging study specific processing and storage of specimens with the laboratory leadership (Tiara_A_Brown@rush.edu or Monica_Rover@rush.edu).
  4. Updated information on arranging and scheduling blood collection by the inpatient phlebotomy team with phlebotomy leadership (Valencia_Sagnia@rush.edu).
  5. Added Suite 439 Professional Building for outpatient blood collection.
  6. Updated contact information for the Technical Laboratory Director (Merih_Tesfazghi@rush.edu).
  7. Updated dry ice purchasing process.
  8. Fund and Cost Center replaced with Activity and Accounting Unit.
  9. Added link to RML test directory for CPT code look-up (https://rml.rush.edu/Pages/Search.aspx).
  10. Added location of the Charge Master (aka Research Fee Schedule) for specific pricing information. 
  11. Corrected CBC with Differential CPT code to 85025.
  12. Removed Test Name “Processing Fee” due to discontinuation by RML.
  13. Added check boxes if Pathology Services requisition needed.

For further questions regarding these changes, please contact:

Corey_J_Woods@rush.edu for questions regarding the Research Project Request Form

Monica_Rover@rush.edu for questions regarding Rush Medical Laboratories
 

Adjustments to the ORA Sync Process 

Date Issued: January 19, 2024

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:

  • ClinicalTrials.gov Registration Determination Page RRP MP Presentation
  • ClinicalTrials.gov Registration Determination Page RRP MP Handout 1
  • ClinicalTrials.gov Registration Determination Page RRP MP Handout 2

Please reach out to clinicaltrialsgov_team@rush.edu with questions and visit the ClinicalTrials.gov folder in the RRP for related tools and resources.
 

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.

Lisa Gazick or Sponsor_Invoicing@rush.edu for questions about Sponsor Invoicing

Lisa Gazick or Research_Billing_Revenue_Cycle@rush.edu for questions about Charge Capture

OnCore_Team@rush.edu for questions about OnCore
 

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:

  1. 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.
  2. 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.
  3. 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.
  4. 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:

  1. 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.
  2. 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.
  3. 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 

OnCore_Team@rush.edu for questions about OnCore

IRB_Team@rush.edu for questions about the IRB Application
 

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:
    • 30 business days prior to sponsor deadline submit advance notice to SPA
    • 10 business days prior to sponsor deadline request budget consultation in RRP
    • 3 business days prior to sponsor deadline issue Department Approval in RRP
  • Easy to use pre-award checklists for PIs, Grant Administrators, and Department Approvers
  • Detailed, chapter by chapter guidance on key aspects of the pre-award process:
    • Chapter 1: Notification and Intake (Grant Administrator / SPA Grant Specialist)      
    • Chapter 2: Finalize Research Plan and Scientific Portions (PI)
    • Chapter 3: Non-Scientific / Administrative Portions (Grant Administrator)        
    • Chapter 4: Budget Creation and Commitments (Grant Administrator)        
    • Chapter 5: Budget Consultation (SPA Grant Specialist)           
    • Chapter 6: Compilation of Documents / Finalizing the Application (Grant Administrator)   
    • Chapter 7: Department Review (Department Chair) 
    • Chapter 8: SPA Review / Submit to Sponsor (SPA Grant Specialist)  

We hope you make use of this new resource. Please reach out to Jennifer Garcia and Jackie Rollin with additional questions.

Location: RRP > Grants > Pre-Award Grant Submission Playbook
 

Informed Consent Form (ICF) Rush Learning Hub Training Modules

Date Issued: January 5, 2021

The Office of Research Compliance (ORC) created online training modules in response to the needs of the research community. 

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

Learners can self-enroll or, in some cases, the ORC is able to assign these modules to employees and/or to those who have exhibited a need for further education post EQuIP audit.
 

Suggested REDCap Language for Publications

Date Issued: January 1, 2021

REDCap requests that the following language be used in publications that used REDCap for data collection and management:

Study data were collected and managed using REDCap electronic data capture tools hosted at Rush University Medical Center.1,2 REDCap (Research Electronic Data Capture) is a secure, web-based software platform designed to support data capture for research studies, providing 1) an intuitive interface for validated data capture; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical packages; and 4) procedures for data integration and interoperability with external sources.

 

1PA Harris, R Taylor, R Thielke, J Payne, N Gonzalez, JG. Conde, Research electronic data capture (REDCap) – A metadata-driven methodology and workflow process for providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377-81.

 

2PA Harris, R Taylor, BL Minor, V Elliott, M Fernandez, L O’Neal, L McLeod, G Delacqua, F Delacqua, J Kirby, SN Duda, REDCap Consortium, The REDCap consortium: Building an international community of software partners, J Biomed Inform. 2019 May 9 [doi: 10.1016/j.jbi.2019.103208]

 

 

REDCap

REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline electronic data capture for research studies and operations.

Rush REDCap by default will allow any Rush employee with a valid Rush user name and password to login into REDCap here.

If you don’t currently have a Rush account or you are not a Rush employee then you will not be able to login to Rush REDCap. Please perform the following steps to request an external/collaborator REDCap account:

  • Fill out the account request form using the following link: REDCap Account Request.
  • Once a user completes the form above, the PI/Sponsor will receive an email notification requesting the PI/sponsor to authorize the user for a new REDCap account.
  • Rush IS will create a new REDCap account and send the account information to the user.

Note: The PI/Sponsor is responsible for sharing the external/collaborator REDCap account request above to the external/collaborator.

Please visit REDCap at Rush University for REDCap Office Hours, FAQs, and more information.

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