Study Tracker

All clinical research studies overseen by the Northwestern University Institutional Review Board (IRB) involving Feinberg faculty, regardless of where performed, are required to provide the information in Study Tracker. The research subject tracking log of Study Tracker is used for all human clinical trials initiated by investigators at Northwestern University and Northwestern Medicine. All clinical studies overseen by the Northwestern University IRB involving Feinberg faculty, regardless of where they are performed, are required to record participants in Study Tracker.

From campus or while on the Northwestern University VPN, you may view the policies here: 

• Feinberg  Clinical Research Participant and Study Information Tracking Policy
• Research Privacy and Confidentiality Policy

All Northwestern University studies deemed Northwestern University IRB approved or external IRB, involving Feinberg faculty and found in Study Tracker, are required to record responses in Study Tracker under the Settings tab for the following sections:

• Study Properties: All of the questions under this section
• Epic: Answer the first question, "Does this study use NMHC medical services?" and if "yes," all subsequential questions displayed
• Financial Settings: Chartstring and SP Number (if applicable)

Additionally, all studies that enroll participants are required to build and maintain a budget in Study Tracker. Research activities and costs that are study and participant based and take place during the course of the study must be entered and tracked in Study Tracker.

Open Northwestern University IRB studies that are deemed IRB approved or external IRB must comply. This does not include studies that are closed or in data analysis phase only. Registry studies that are solely used for the purposes of contacting interested registrants for future studies generally do not need to record their participants into Study Tracker.

Those participants that have consented into the study should be recorded and have their signed consent form uploaded to Study Tracker. All consented participants must be logged within one business day of the completion of the consent and have the consent form uploaded within 14 days.

Participants who were screened or failed screening do not need to be entered unless medical services were administered and participant tracking is required.

Yes! On December 12, 2022, Research Workflow Training was provided to the research community. 

Research Workflow Training is for individuals involved in Feinberg’s clinical research enterprise. The training provides instruction on compliance with Feinberg’s Clinical Research Study Information and Participant and Tracking Policy covering topics such as, basic study information required to be entered into Study Tracker, participant enrollment and consent, budget building, and integrations with data security plans and EDW exceptions. The course will also cover NMHC-specific requirements for studies when NMHC is listed as a site of research.

The training video is now accessible on Northwestern University's myHR Learn.  Access the Feinberg Research: Research Workflow Training, Course ID: FSMRWT-100.  The slide presentation can be found here while connected to the NU Network. 

You must record each participant's first and last name, date of birth, NIH race and ethnicity, gender, consent and completion dates. You must also upload a scanned copy of the full, signed initial consent form.

If the study performs NMHC medical services for research, the participant’s profile must include the MRN profile, which can be validated with the MRN look up feature.

Re-consented events and consent forms are not required to be entered into Study Tracker for compliance, but can be recorded for the benefit of the study team.

The consent document is attached to the participant record in Study Tracker. Only those study team members who are listed in eIRB+ as a Project Contact will have access to the documents.

If you do not collect date of birth as part of your consent, there is the ability to collect year of birth. If you are collecting age only, then you should calculate the year of birth based on the age at the time of the consent. If you have participants over the age of 89 and you are not collecting their date of birth, please record their date of birth as 1/1/(correct year of birth).

If you are not collecting demographics, you should select the "Unknown/Not Reported" option as to acknowledge this.

All clinical research studies overseen by the Northwestern University IRB involving Feinberg School of Medicine faculty, regardless of where performed, are required to provide the study details in Study Tracker.

Support Services is a section within Study Tracker where the Feinberg groups that provide support services to study teams are recorded. In order to adequately track and provide resources for each study, the Support Services section for each study must be completed.

Complion is required for FDA-regulated studies and those that are multi-site. Please reference both the Complion policy and the Feinberg Research Complion page for more information.

Beginning July 1, 2022, you will be able to view the status of the data security plan submission for a study on the Compliance tab in Study Tracker.

Reach out to the Feinberg IT security team at FSMIT-policy@northwestern.edu.

This process is for non-Northwestern Memorial HealthCare (NMHC) employees seeking to gain access to NMHC systems, facilities and/or patients for the purpose of research. Paid employees of an NMHC-affiliate (Northwestern University, Ann & Robert H. Lurie Children’s Hospital of Chicago, Shirley Ryan AbilityLab and Edward Hines, Jr. VA Hospital) seeking access for the purposes of research are expected to obtain access and Clinical Practice Privileges via the NMHC Access Program.

New employees will need to complete the Access Program application in order to gain access to NMHC and to obtain a NMID. If you have already gone through the process, you do not need to do it again. Only those staff members who are not current access participants need to go through the process.

NMHC access information can be found via the Access Program Manual.

Northwestern University will provide a certificate of insurance coverage to NMHC for non-university employees (interns/volunteers). Non-employee research access information can be found via the Non-Employee Research Manual.

In order to review electronic health record data for the purposes of research, you are required to use an enterprise data warehouse (EDW) report. When data are not available in the EDW, an exception to review the record directly may be granted on a study-by-study basis. For more information on that process, review the EDW Exception Process FAQ.

Review the EDW Workflow Tipsheet for more information on how this process is integrated with Study Tracker.

A study will appear in Study Tracker within one day of it receiving a Northwestern University IRB-approved or external IRB status in eIRB+. Exempt and Non-Human Research IRB statuses can be manually added to Study Tracker if requested and approved. Requests for the addition of studies can be emailed to studytracker@northwestern.edu.

Once a study team member is added to the project contacts list to a Northwestern University IRB-approved or external IRB study in eIRB+, they will automatically be granted access to that study in Study Tracker.  eIRB+ and Study Tracker sync nightly; therefore, once a study team member is approved in eIRB+ the newly approved study team member will gain access the next day. NetID credentials are required for Study Tracker log-in.

The most common access is that of a study team member. While the general access to the study is automatically imported to the study once approved on the Project Contacts List in eIRB+, those with
"write" permissions for "users management" can control the level of study access a study team member should have under the "users" tab. Access levels for study settings, subject, study budget and potential subjects can be selected as write, read only or none.

ORG access is granted on a case-by-case basis for those who oversee studies on a departmental level. ORG access requires the completion of CITI Training and approval. ORG access requests can be sent to studytracker@northwestern.edu.

If a study team member is required to access a study in Epic for research purposes,  they will need to be added to a separate access list specifically for the viewing of studies in Epic.  In the "Epic" section under the Settings tab in Study Tracker, you will find at the bottom of the page the section labeled "Study Team Members with Access to Epic." Adding a user to this list will control whether a Study Team member can view the study and all of its synced subjects in Epic.

All access to Study Tracker requires a valid Northwestern University NetID. Only the IRB authorized PI, co-investigators and coordinators who are listed in eIRB+ will be able to view the study details and identity of subjects accrued on a study.

Important research study details recorded in Study Tracker are communicated to Epic. When a list of requirements are met in Study Tracker for a study, communication is sent to Epic to create a RSH record and allow for encounter linking in Epic.

If any of the requirements outlined in the FSM/NMHC Research Workflow document are missing, the study will not sync to Epic.

Participants will only show in Epic if the most recent activity in Study Tracker is an activity that is listed as an "Active Activity." Refer to the Enrollment Status chart for a full list of all the activities.

Once a participant is recorded with an inactive activity (see Enrollment Status chart) in Study Tracker, the participant will drop off your Epic dashboard EXCEPT the blue section labeled "Study Population." Inpatient admissions will remain on this list for 30 days despite the inactive activity status. After 30 days all participants with an inactive activity status will be removed from all sections of your Epic dashboard.

Only study team members listed under the section "Study Team Members with Access to Epic"  can view the study and all of its synced subjects in Epic (see the Access section on this page).

These linked Epic tip sheets demonstrate two ways to link a participant to a study: 1) how you link an encounter to a research study and 2) how to link an admission to a research study.

Participant Tracking is the main communication between the Study Team and NMHC Office of Research that communicates what research services were actually completed as part of a research study. It is essential this action is completed because it is a key set in ensuring that a study is billed correctly for NMHC medical services performed for research and not the subject or their insurance. Participant Tracking is completed in Study Tracker. You may enter the Participant Tracking section by entering under the "$ Finances" at the study level or via the "Budget Tracking" tab while in a Subject's profile.

The locked budget should reflect the visit schedule for each budget arm and visits should be tracked within one calendar day so that confirmation of the scheduled medical services performed can be recorded and later matched by the Office of Research for billing.

Refer to the Participant Tracking in Study Tracker guide for a detailed outline of the steps and requirements to complete this task.

This slide is a quick overview of critical timelines for research billing compliance.

The Study Budget Setup Guide includes a detailed description of how to complete this task.

The Coverage Analysis Guidelines and Process document should be reviewed by all study teams who operate studies with NMHC as a site of research.

The Coverage Analysis Appeals Process Overview document outlines the appeals process for a coverage analysis completed with studies at NMHC.

NMHC Invoices for research can be found on the "Compliance" tab in Study Tracker. Locate your study's research invoices with ease by viewing the Latest NMHC invoice from the main page or click on "see the full list of invoices" to view an historical list of invoices with the option to reconcile or archive an invoice.  

Please refer to the invoice for details on who to contact for invoice specific questions.

If you are an Org User in Study Tracker, you can see all of the invoices at once for your unit by going to Orgs tab -> your Org Name -> NMHC Research Statements

If you have access to NUfinancials, you can pay the invoice directly via the Payment Request Center page. Create a new payment request and enter details about the invoice such as invoice number, amount, etc. Then input the chart string that you would like to use. Once information has been filled out successfully, you can submit payment.

If you do not have access to NUfinancials, contact your department’s financial coordinator with payment questions.

For instructions on how to make a Payment Request, please visit your MyHR training portal and search for the training titled, "Payment Requests in NUFinancials (eLearning)."

Once payment is submitted and goes through the necessary approvals, payment will be made immediately via a wire transfer.

If the budget created does not have any of the services/procedures marked as "Provided by NMHC," then NMHC Office of Research cannot view and complete the Secondary Review.

NMHC should be marked within the budget at the service/procedure level.

Once at least one service/procedure is marked NMHC within the budget, you will see NMHC Code & Charge review options on the top banner on your budget page.

Yes. If the NMHC Investigational Pharmacy is used for the study it must be recorded in Study Tracker to indicate this. "NMHC Research Pharmacy" is listed under NMHC Site in the Affiliations section under the Settings tab in Study Tracker. Click "Edit Affiliations," check "NMHC Research Pharmacy," and Click "Save."

Policy documents for the NM Investigational Drugs policy and the Use of Investigational Pharmacy Policy outline further details and requirements. 

Services that are part of standard of care do not require participant tracking. However, when the patient receives research services, even at the time of a standard of care visit, the patient must be entered into Study Tracker and participant tracking must be completed to prevent incorrect billing.

If you are unable to find a medical service while editing your "Medical Services" list in Study Tracker, remember that you can search by service name, description or CPT/Procedure Code. If you determine that your service is missing from the list, please notify Madeline Dones at NMHC.

Yes, however, you cannot perform participant tracking while the budget is unlocked. Navigate to "$ Finances" tab and locate the "Configuration" button and then "Unlock" the budget to make changes. Don't forget to lock the budget once the appropriate changes have been made. 

All clinical research studies overseen by the Northwestern University IRB involving Feinberg School of Medicine faculty, regardless of where performed, are required to provide the study details in Study Tracker.

Every Feinberg study should have a chartstring affiliated with it. For example, personnel time, including the PI’s time to run the study, medications or medical services would all be paid for from Northwestern University funds. The aim of the policy is to identify and document those funds that pay for clinical research. The only studies that would not have a chart string are studies funded solely through the Shirley Ryan AbilityLab or Ann & Robert H. Lurie Children's Hospital of Chicago. If your study does not have a chartstring, you will have to change the default answer of "yes" to "no" and then select from the options provided for you.

Questions about the chartstring requirements can be emailed to fsm_study_info@northwestern.edu.

SP numbers can be found in the InfoEd Portal (a link is provided in Study Tracker). Only those study team members who are associated with grant submission will have access to InfoEd. They may provide another study team member with this number to enter and store in Study Tracker. Also, study team members with access to InfoEd can login to the InfoEd system directly to associate the STU number to the SP number.

If your study does not have an SP number, you will need to change the default answer of "yes" to "no."

The NMHC Fiscal Year 2022 Research Pricing Catalog is now available. You may download the full catalog, with pricing, from a secure connection by clicking on the catalog name below:

• NMHC FY22 Research Catalog
• NMG FY22 Research Catalog
• FY22 Investigational Drug Service Fee Schedule (found under NMHC FY22 Research Catalog within Study Tracker)

Please remember to review your current study budgets to ensure that you update any deprecated services with updated CPT codes from the current Research Catalog. A deprecated service code will be noted in the description and should be removed from the budget and replaced with a new cpt code from the current FY22 Research Catalog.

If you need more information or have questions about any of the individual catalogs or their contents, please contact Madeline Dones at mdones@nm.org.

• Research type, approval and study expiration dates and other details are pulled from the electronic IRB as soon as your protocol is approved
• Patient demographic information (e.g., age, gender, ethnicity)
• Patient diagnosis information
• Patient consent, withdrawal and study completion details
• Information about patient research services rendered at partner institutions (e.g., blood draws, laboratory workups, imaging)
• Medical Record Numbers from Northwestern affiliates, including Northwestern Memorial HealthCare (NMHC) and Northwestern Memorial Group

Study Tracker speeds data entry because study information, including the key personnel list, are automatically filled in from IRB data.

You can quickly and easily add subjects to your study and track patient status and any other patient information you need. Study Tracker reduces errors with automated medical record number lookup.

You can visualize accrual numbers and trends for all of your studies in one location. Study Tracker lets you prepare reports for accrual and visits by day of the week and month to identify busy time periods and help you appropriately allocate resources.

Study Tracker meets HIPAA and Northwestern Medicine standards for data privacy and security.

Study Tracker only allows IRB-approved personnel to view the identity of subjects accrued on a study.

Study Tracker helps investigators comply with institutional clinical research billing (CRB) requirements:

• To facilitate accurate billing and CRB compliance, participant tracking must be completed every time a patient enrolled in a study tracked by Study Tracker has an outpatient clinic visit and receives research services from our NMHC affiliates.
• You can generate a variety of reports, including NIH inclusion enrollment reports, patient demographic information reports and Northwestern Medicine Enterprise Data Warehouse reports.

Using other NUCATS and Northwestern University software and resources can help simplify your research process. For help picking which combinations will work best for your needs, please contact the Bioinformatics Research Navigator.

Suggested Software

• Northwestern Medicine Enterprise Data Warehouse
• REDCap

Suggested Resources

• The Center for Clinical Research provides research study support, including IRB submissions and patient recruitment.
• The Clinical Research Units offer patient visit sites.
• The Biostatistics Collaboration Center provides analytic services including research design, data management and determination of inclusion criteria and outcome measures.
• Research Navigators provide consultative services for NUCATS resources at your disposal through all stages of the scientific process, including trial design, IRB submission, patient identification and recruitment, software services and data analysis.

Study Tracker is considered a campus system, much like eIRB+ itself, and does not require approval or special language in your consent form. All clinical research studies at Northwestern are eligible to use Study Tracker, and all non-exempt biomedical research studies are automatically loaded and available to individuals listed in the Project Contacts List of the IRB submission.

All Study Tracker users have CITI training, as validated by the IRB. Study Tracker does not raise any additional security or HIPAA-related issues.

Study Tracker can retrieve completed eConsent PDFs from REDCap. The PDFs are retrieved one participant at a time and not as a bulk load. Your study team will have to add an eConsent event manually for each participant in Study Tracker for the retrieval of the PDF form from REDCap to take place. ALL of the requirements for your REDCap project are outlined in the eConsent Study Tracker Push/Pull from REDCap Feature handout.

Please note that this feature will not work until ALL of the REDCap project requirements are met.  After your request has been submitted to Study Tracker Support please allow one to two business days. Study Tracker Support will confirm all requirements were met correctly before enabling the feature. You will receive an email confirmation once the review has been completed and/or the feature has been enabled.

The information fed into the Feinberg Research list of trials page is the information recorded under the Recruitment section in Study Tracker. Follow the steps included in the Recruitment document for details on how to have a study added to this list.

Please refer to the Electronic Recruitment Through the Medical Record procedure document for details. This document is only available while on the Northwestern University network.

If your study is recruiting and a COVID-19 study, in addition to the general requirements for the Feinberg Research list of trials page, there is an additional step that must be met. Details can be found at the bottom of this Recruitment document.

Since the systems sync nightly, tomorrow you will see your study in the following places:

• The websites of the departments, divisions, institutes and centers with which your study is affiliated
• The faculty profile of the study’s PI 
• The main Feinberg Research clinical trials listing

For more information, please complete the Feinberg Office of Communications’ web team contact form.

Cancer-relevant studies should still affiliate with all appropriate departments and centers (including the Robert H. Lurie Comprehensive Cancer Center of Northwestern University) and complete all the required fields under Settings > Recruitment.

There is an additional Diseases field in the Recruiting section for cancer-relevant studies. This field informs where the study will appear in the Lurie Cancer Center site. If you do not associate your study with a disease type, it will not show for users on the Types of Cancer disease-specific lists. You can associate with as many types as is appropriate. This field will auto-populate with available options as you type.

Please note: Keywords will not appear with study entries on the cancer center site.

When recruitment is enabled in Study Tracker, your study can appear on the Feinberg Clinical Trials page, NM Clinical Trials & Research page and under the "Clinical Trials" tab on the PI’s faculty profile on the Feinberg site. Please make sure the Recruitment tab form in Study Tracker is filled out correctly to make sure your study is displayed.

Check Study Tracker to be sure that your study is properly affiliated under Settings > Recruitment and make sure the following elements are completed:

• "Would you like to recruit publicly?" checkbox is checked
• Primary recruiting contact information
• Public/Lay study description
• Diseases/Clinical areas

If you continue to have issues with displaying your study after confirming the above is correctly recorded in Study Tracker, please complete the Feinberg Office of Communications’ web team contact form.

Simply go to the Settings > Recruitment section in Study Tracker and uncheck the “Would you like to recruit publicly?” checkbox. When this box is unchecked, it prevents the information recorded under this section to send to the outside sources. If the box is checked and then unchecked because recruiting has ceased, the systems will sync overnight and you will no longer see the study listed publicly for recruiting the next day.