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Study Tracker

Study Tracker is a set of web-based clinical research tools help to improve efficiency, safety and security for subjects in scientific studies. Study Tracker has logged more than 6,000 studies with nearly 80,000 patient accruals. In 2013 alone, there were more than 1,500 studies initiated.

Study Tracker is a free application. To access Study Tracker, simply log in from the University network using your NetID and password to see the studies you're authorized to view. This link will only work off-site if you are already connected via the NU VPN or by logging in via the SSL VPN

For more information, review the frequently asked questions below. If you still can’t find the answer to your question, please email studytracker@northwestern.edu.

Frequently Asked Questions

FSM Policies

This section will outline how usage of Study Tracker assists with compliance of Feinberg School of Medicine Policies for your research study. 

 Do I need to use Study Tracker?

All clinical research studies overseen by the NU IRB involving FSM 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 Institutional Review Board involving Feinberg School of Medicine faculty, regardless of where they are performed, are required to record participants in Study Tracker.

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

 What study information is required to be recorded in Study Tracker?

All Northwestern University studies deemed NU IRB Approved or External IRB, involving FSM Faculty and found in Study Tracker, are required to record responses in Study Tracker under the Settings tab for the following sections:

  1. Study Properties - All of the questions under this section.
  2. Epic - Answer the first question, “Does this study use NMHC medical services?” and if “Yes” all subsequential questions displayed.
  3. Financial Settings - Chartstring & 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.

 Which studies require compliance with the FSM Clinical Research Participant and Study Information Tracking Policy?

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.

 Which participants need to be registered in 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.

 What participant information is required for compliance?

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. 

 What will be done with consent documents once they have been uploaded to Study Tracker and who will have access?

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. 

  What participant information do I need to record if I do not collect the date of birth or demographics as part of my consent?

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.  

 If my study does not bill medical services at NMHC, is this policy still applicable to my study?

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.

 What are “Support Services” and why must they be recorded?

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.

supportservices.jpg

Access

This section will outline the various types of access related to Study Tracker including access that feeds permissions to other systems, i.e. Epic.

 What is the NMHC Access program and who is this program for?

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 (NU), Ann & Robert H. Lurie Children’s Hospital of Chicago (Lurie Children’s), Shirley Ryan Ability Lab (SRALab), 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.

 I am an intern or volunteer that will be working on research at NU. How do I obtain access?

As of November 2018, an agreement between Northwestern University (NU) and Northwestern Memorial Healthcare Corporation (NMHC) was executed to outline the requirements for individuals who are not employed by NU to contribute to NU research conducted at NMHC clinical affiliates. As part of this Agreement, NU will provide a certificate of insurance coverage to NMHC for non-NU employees (interns/volunteers).

Non-Employee research access information can be found via the Non-Employee Research Manual.

 What is an EDW Exception and why is it needed?

You will need to have an approved EDW exception in order to have “chart review” access.  An EDW exception is needed for direct access to the patient chart.  You do not need an exception to receive data from the EDW. For more information on that process, review the EDW permissible use policies.

 How does a study appear in Study Tracker?

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

 How does a Study Team member gain access to a study in Study Tracker?

Once a Study Team member is added to the project contacts list to a NU 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.  NU NetID credentials are required for Study Tracker log in.

 What types of access are there for study team members in Study Tracker?

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.

user-rights.jpg

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

 How does a Study Team member gain access to the study in Epic?

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 or not a  Study Team member can view the study and all of its synced subjects in Epic.

epic-section.jpg

 

 What credentials are required for accessing Study Tracker?

All access to Study Tracker requires a valid NU 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.  

Study Tracker & Epic

Learn more about how Study Tracker and Epic work together in this section.

 How do Study Tracker & Epic communicate?

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.  

 Why can't I see my study in Epic?

If any of the requirements outlined in the Epic Record Creation Reference Guide are missing, the study will not sync to Epic.

 What activities push a participant 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.

 When will a participant be removed from my Epic dashboard?

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.

 Who can link an encounter for my study in Epic?

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 of this FAQ).

epic-section.jpg

Research Financials

This section outlines the management of research study financials in Study Tracker with Study Budget.

 What is Participant Tracking and why is it necessary?

Participant Tracking is the main communication between the Study Team and the Office of Research ensuring that the 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 business 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 Research Workflow in Epic and Study Tracker Guide for a detailed outline of the steps and requirements to complete this task.

 How do I set up the new required budget?

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

 Why can't the OOR see my study to perform Secondary Review of my tracked participant?

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

NMHC should be marked within the budget at the service/procedure level as depicted below: 

providedbynmhc.jpg

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 as depicted below: 

chargereview.jpg

 What happens when I have a patient receiving both standard of care and research services?

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.

 What if my CPT or procedure code is not in Study Tracker?

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.

 Can I amend a locked budget?

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. 

configuration_button.jpg

Don't forget to lock the budget once the appropriate changes have been made. 

 If my study does not bill medical services at NMHC, is this policy still applicable to my study?

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.

 What do you enter in to Study Tracker if there is no chart string for the study?

Every Feinberg study should have a chart string 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 Lurie Children's Hospital. 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.

 How can I obtain the SP number associated with my study?

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.”

 Where can I locate the current charge master with pricing?

You can locate the most current NMHC Charge Masters and other important notices from the OOR in the NMHC Corner.

System Details

Study Tracker benefits your research studies in many ways, learn how in this section.

 What type of information does Study Tracker capture?

  • 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

 How does Study Tracker help me?

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.

 Can I use other software or resources with Study Tracker?

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

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.

 Is Study Tracker IRB approved? Do I have to update consent language?

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.

 Is Study Tracker secure and/or HIPAA compliant?

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

 How do I link Study Tracker with my e-consent project in REDCap?

Study Tracker can retrieve 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 order to retrieve the PDF from REDCap. After ensuring your REDCap project meets ALL of the requirements below:

  1. The eConsent project exists on Northwestern's instance of REDCap.
  2. Only one REDCap project at a time can be linked to an STU in Study Tracker (one REDCap API per study).
  3. The project does not have longitudinal feature enabled.
  4. "Record_id" is the first field on the first instrument.
  5. An instrument named "econsent" exists in the project.
  6. The field"consent_date" exists in the project and "consent_date" has field validation in the format yyyy-mm-dd.
  7. The field "case_number" exists in the project; and must be unique for each record.
  8. If using the eConsent Framework in REDCap, you must enable the option “Allow e-Consent responses to be edited by users?” under Survey Settings. 
    econsentframework.jpg
  9. Add the user "study_tracker_webservice" to your project with API import/export rights and "Full Data Set" privileges under "Data Export" rights.
  10. Email a request to studytracker@northwestern.edu to link your STU in Study Tracker to your REDCap project. Please include REDCap project name and project ID in your request.

Note:  Once this feature is enabled, two key steps need to take place for the feature to work correctly: 1.) In REDCap, the study team member must edit the signed consent form by appending the assigned case number to the consent form and ensuring the status of the form is “completed.”  2.) In Study Tracker, you must record the subject with the matching case number before you record the activity of “econsented” (not consented).  This will enable the systems to identify and pull the matching consent form for the record.

Recruitment

Learn how to expand your study recruitment efforts with Study Tracker in this section.

 How does my study appear on the FSM Research list of Trials on the public facing website?

The information fed into the FSM 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.

 How does my study appear on the public facing website for COVID-19 Clinical Trials page?

If your study is recruiting and a COVID-19 study, you can add it to the list on the COVID-19 Clinical Trials page.  In addition to the general requirements for the FSM 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.

 I’ve opted in and provided all the necessary information and affiliation. What happens next?

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 Office of Research Clinical Trials listing

For more information, please contact Feinberg Office of Communications’ web team at medweb@northwestern.edu

 How do I display my cancer-relevant studies?

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. 

 What websites receive the recruiting information when enabled in Study Tracker?

When recruitment is enabled in Study Tracker, your study can appear on the FSM Clinical Trials pageNM Clinical Trials & Research pageCOVID-19 Clinical Trials page and under the “Clinical Trials” tab under the PI’s Faculty Profile on the FSM site.  Please make sure the Recruitment tab form in Study Tracker is filled out correctly to make sure your study is displayed.

 I don’t see my study listed anywhere for recruitment. What should I do?

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 contact Feinberg Office of Communications’ web team at medweb@northwestern.edu

 My study is not recruiting. How do I get my study off the public website?

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.

Study Tracker Resource Library

 Quick Access Links to Documents & Resources

 What kind of assistance is there for Study Tracker?

Email questions about your study to the Study Tracker Support team at studytracker@northwestern.edu. You can also seek assistance by registering for a time slot during our Study Tracker Office Hours.
Participating Institutions: