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Northwestern University
Clinical and Translational Sciences Institute

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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. 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.

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 not work if you are off-site. Please use a VPN for remote access.

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

Study Tracker & Epic Updates

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

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

You must be signed in from campus or via the VPN to access the documents listed above.

 Do I need to go through the NMHC Access program?

In order to gain access to NMHC and to obtain a NMID (for new employees), you will need to complete the Access Program application. 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.

 What is Participant Tracking and why is it necessary?

Participant Tracking is completed in Study Tracker under the "$ Budget" tab by a Study Team member.  Participant Tracking is the main communication between the Study Team and the Office of Research to ensure that the study is billed for NMHC medical services performed for research and not the subject or their insurance. 

The budget should reflect the visit schedule for each 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 following guide for a detailed outline of the steps and requirements to complete this task: 

Research Workflow in Epic and Study Tracker Guide 

 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.

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

Study requirements:

All Northwestern University IRB-approved studies found in Study Tracker are required to answer all of the questions found under the "Study Properties" section located under the "Settings" tab in Study Tracker. Additionally, if your study meets the following criteria, you will have to also answer all of the questions under the "EPIC Billing" tab:

  1. NMHC is recorded as a site in eIRB+ and NMHC is listed as an Affiliation under the "Affiliations" section
  2. You answered "yes" to the following question under Study Properties: "Does this study use billable NMHC medical services after March 3, 2018?"

 How does a Study Team member gain study access?

Study Team Member User Requirements: 

  • Study Access in Study Tracker: Study Team members are automatically granted access to studies in Study Tracker once they have been listed in eIRB+ as a Study Team member (under Project Contacts).  Allow 24 hours from the time a Study Team member has been added in eIRB+ for Study Tracker to reflect their automatic access.  NU NetID credentials are required for Study Tracker log in. A list of all the approved user access to the study is found under the "Users" tab in Study Tracker. 

  • Study Access 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 vieiwing of studies in Epic.   Under the "Epic Billing" tab in Study Tracker you will find at the bottom of the page a section labeled, "Study Team Members with Access to Epic."  Adding a user under this section will control access so that a Study Team member can view a study and all of its synced subjects in Epic. This level of Epic access is different than Chart Review access.  

 How do I set up the new required budget?

Please refer to the Study Budget Setup Guide for a detailed description.

 Why can't I see my study in Epic?

There are a list of requirements that need to be met in order for a study and participant to be displayed in Epic to complete encounter linking.  Please refer to the Epic Record Creation Reference Guide for further details.

 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.

 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 can not view and complete the Secondary Review.

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

  nmhc.png    

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: 

nmhc-review.png

General Study Tracker Questions

 Do I need to use Study Tracker?

All clinical research participants must be entered into Study Tracker. Studies using medical services from NMHC (including Northwestern Medicine Lake Forest Hospital and NMG) must continue to use Study Tracker to create study budgets and submit eSPRVs. From campus or VPN, you can view the Feinberg School of Medicine Participant Tracking Policy for more information.

 How do I get started with Study Tracker?

Your study must be approved in eIRB+ first. If you have any questions, email studytracker@northwestern.edu.

 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.

You can alert patients to important dates and incomplete forms with the built-in study calendar function. The schedule can be based off of an event, such as a service or form to be filled out, and set to automatically notify the necessary patient or group of patients.

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 reduces the risk of inaccurate billing and helps investigators comply with institutional clinical research billing (CRB) requirements.

  • To facilitate accurate billing and CRB compliance, an eSPRV must be filled out 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 connect with common software applications, such as Excel, for reporting and analysis.
  • 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.

 How is access granted and managed on Study Tracker and who will be able to add/view subjects accrued on a study?

Study Tracker is only available from your institution's secure network or VPN. In order to gain access to Study Tracker, you will need the following:

  1. You must be on your institution's secure network or VPN.
  2. You must have a valid Northwestern University netID and password.
  3. You must have up-to-date CITI training (or equivalent). This is enforced by the IRB.
  4. You must be listed on the Authorized Personnel List (APL) of at least one approved study entered in the Northwestern eIRB database. Access to specific approved studies is automatically granted to those listed on the APL in IRB for that study. All users must also have a role assigned in eIRB. Corrections should be made directly with the IRB.

You cannot view your study in Study Tracker if:

  • You are not on the APL. If you are listed as "non-NU personel" or on the "Study Access" list you will not be able to view your study in Study Tracker.
  • Your role is missing from eIRB APL. Users on the APL with missing or unknown roles can not view their study in Study Tracker.
  • The study has not been approved in eIRB (if Project State in eIRB is "under review" or "pre-submission").

Only the IRB authorized PI, co-investigators and coordinators who are listed in eIRB will be able to view the identity of subjects accrued on a study. Any additional roles and responsibilities should be clarified with the IRB and added to the authorized personnel list in eIRB+.

The IRB is committed to providing expedited review and implementation of faculty and staff changes for any IRB study. The University has immediate termination of access procedures in place, including netID cutoffs synchronized with physical notification in cases of employee termination. All access to Study Tracker requires a valid NU netID. In our experience, an expedited authorized personnel request change with the IRB is often in place 24 hours after submitting the change to the IRB. External IRB studies, with CIRB, must manage their own IRB APL.

 What is Charge Review and when is it necessary?

Charge Review must be completed by close of business the same day a study participant receives medical services at NMH, NMG or NMLF. Charge Review is required for all patient types receiving services. It's required for inpatients and bedded outpatients except for those studies at NMH where the NMH Admitting and Registration form for bedded procedures is used.

 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 charge review; 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 charge review must be compelted 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.

 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 APL 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.

 I work at a University affiliate. How do I get a net ID?

The department where the affiliation resides (where your PI belongs) must submit a request for an Affiliate ID. Contact the department for more information.

 How do I create a budget?

The following four conditions must be true before adding medical services to your budget for NMHC approval:

  1. Your study is compliant with Feinberg policies.
  2. "Northwestern Memorial HealthCare and/or its affiliates" must be listed as a study site in the IRB system. You can confirm this by navigating to "Settings" then "Affiliations" in Study Tracker. You should see NMHC and its affiliates checked under "Sites."
  3. Study information is complete. Navigate to "Settings" then "Study Properties" to make sure your study information has been recorded correctly.
  4. Epic Billing information is complete.  The Epic Billing tab appears once the answer 'Yes' for NMHC services is recorded under the Study Properties section.  All details under Epic Billing must be recorded.

Once you've met these conditions, navigate to the "$ Budget" tab to create your budget. You can add services by name or CPT Code and can use a study appropriate naming convention for your Budget Arms. All study budgets must be "locked" in order to track against them (perform charge review). 

 How do I amend a budget?

Navigate to "$ Budget" tab and "Unlock" the budget to make changes.  Don't forget to lock the budget once the appropriate changes have been made. 

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

Study Tracker can retrieve e-consent 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 e-consent event manually for each participant in order to retrieve the PDF from REDCap. After ensuring your REDCap project meets the requirements below, please reach out to the Study Tracker team so we can enable this feature for you.

  1. The e-consent 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.
  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 fields "consent_date" and "case_number" exist in the project; "case_number" must be unique.
  7. "consent_date" has field validation in the format yyyy-mm-dd.
  8. Your participants' "case_number" values in the REDCap e-consent project must match their case numbers in Study Tracker.
  9. Forms must have a status of "Complete"' in REDCap before Study Tracker can fetch them.
  10. Add the user "study_tracker_webservice" to your project with API import/export rights and "Full Data Set" privileges under "Data Export" rights.
  11. 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.

Study Recruitment Questions

 Does my department offer the public web-based recruiting solution?

Not all departments and centers offer this solution on their websites. Some units have not been onboarded, and some do not conduct or publicly recruit for clinical trials. Departments that don’t currently display the solution include: 

  • Basic Sciences (Pharmacology, Physiology, Cell and Molecular Biology, Biochemistry and Molecular Genetics and Microbiology-Immunology)
  • Emergency Medicine
  • Medical Social Sciences
  • Ophthalmology
  • Orthopaedic Surgery
  • Otolaryngology
  • Pathology
  • Pediatrics
  • Radiation Oncology

If you would like to publically recruit your study, please affiliate will any appropriate units, even if they do not display the solution on their websites. 

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

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

Not all department and center websites offer this solution. For more information, please contact Feinberg Office of Communications’ web team at medweb@northwestern.edu

 I don’t see my study on the website. What should I do?

Look at the trial in Study Tracker. Check to be sure that your study is properly affiliated under Settings>Recruitment. Under the Settings>Recruitment section, make sure the following elements are completed:

  • "Would you like to recruit publicly?" checkbox is checked
  • Primary recruiting contact information
  • Public-facing information

If you continue to have issues with displaying your study, 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>Recruiting. 

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. 

 How do I get my study off the public website?

Simply go to the Settings>Recruitment section and uncheck the “Would you like to recruit publicly?” checkbox.

Policies

You may view the policies here when signed in from campus or via VPN: 

 Which studies require compliance with the Feinberg School of Medicine Participant Tracking policy?

Open studies that are Northwestern University IRB approved 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 participants recorded must be logged within one business day of the completion of the event. 

Participants who were screened or failed screening do not need to be entered unless medical services were administered and an eSPRV was 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. 

Re-consented events and consent forms are not required to be entered/uploaded to Study Tracker for compliance, but can be recorded/stored 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. The same authorized personnel who have access to the participant record will have access to the consents. You control that access with your authorized personnel list in the eIRB system.  

 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.  

 What does the Clinical Research Study Information Policy require?

Studies must be updated in Study Tracker to include the SP number, chart string and associate all support services.

 If my study does not bill medical services at NM, 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.

 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.

 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 STU number must be completed.

 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 I have questions about the chart string requirements, whom do I contact?

Please send an email to fsm_study_info@northwestern.edu.

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Participating Institutions: