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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 & Project One Updates

Review the Access Program Manual. You must be signed in from campus or via VPN.

 How will Project One affect me and my Northwestern University IRB-approved research study?

Access: Access to Epic will be changing after Project One due to the new research module that we will be using. In order to have the correct access, you must request it individually.

Roles: Your access to certain aspects of the study will change depending on what role you play within the study. New roles have been determined as Chart Reviewer and Charge Reviewer.

Billing: If your study has NMHC services that will be billed to the study after March 3, 2018, the current process for billing the study (eSPRV) will be replaced with an enhanced way of tracking and matching all study-specific expenses, whether they are NMHC or non-NMHC medical service fees.

 Do I need to go through the NMHC Access program?

In order to gain access to NMHC for charge review or chart review, you will need to be an Access participant. 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.

 What types of access will exist for research after Project One go-live?

There are two types of access: Chart review access and charge review access.

Chart review access is direct access to view the patient chart. Charge review is direct access to review the charges incurred during a research visit.

Each access level is requested individually. No access is granted automatically.

 What is a charge review list, and what will someone who is on the CRL expected to do?

The charge review list (CRL), found in Study Tracker, is comprised of members of a department or study team who will review research related charges that occur at NMHC.

The charge review process will be similar to the eSPRV process, but will be pushed forward in terms of billing timing and will take place within EPIC. In the new research billing workflow, the eSPRV process in Study Tracker will no longer exist. You or someone on your study team will build a budget in Study Tracker’s new budget module. The study team will also track all activities that occur on the research visit against that budget. You will use that information to verify charges that appear for billing in your worklist in Epic.

Anyone who will know and be responsible for verifying what events happened on a study with a particular participant on a particular date will need to be on the CRL. This is someone who is responsible for submitting an eSPRV in the current workflow and who will be responsible for charge review using the new process. Additionally, study team members who need to review participants on a study in EPIC and to see those patients and studies in their EPIC dashboard, should be added to the CRL.

PIs are not required to be added to the CRL but can be added if they will be reviewing charges for the study.

 What do I need in order to have access to the charge review list, and when do I need it by?

Credentials: In order to be trained properly for your new role, you will need an NMID. You will need to start the NMHC Access Program process to obtain an NMID (if you are not currently an access participant).

Training: You will also need to complete the appropriate training prior to March 3, 2018, Project One go-live.

 Do I need an EDW exception to receive data from the EDW, and how is this related to access?

You do not need an exception to receive data from the EDW.

You will need to have an approved EDW exception in order to have “chart review” access. This is direct access to the patient chart, and is not located in the same tab as charge review. For more information on that process, review the EDW permissible use policies.

 What do I need to do to now?

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. If your study meets the following criteria, you will have to also answer all of the questions under the "EPIC Billing" tab:

  1. Your study has a NMHC Affiliation recorded in eIRB+
  2. You answered "yes" to the following question under Study Properties: "Does this study use billable NMHC medical services after March 3, 2018?"

User requirements:

  • I am an access participant: If you will be reviewing charges in Epic as a result of P1, you will need to indicate this on the "Epic Billing" tab in Study Tracker for each of your studies (Settings > Epic Billing > Study Team Members with Access to Epic). We will use this information to assign individuals to training and provision access.

    If you need chart review access, you must have an approved exception prior to the Project One go-live.

  • I am not an access participant: You should start the Access Program process so you can be provisioned an NMID. This ID will be required for training. The charge review access will not exist until go-live in March, so you cannot be granted Epic access until that time.

    Once you have completed your Access Program application, you will also need to complete the steps listed above under "I am an access participant."

 How do I set up the new required budget?

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

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.

 How do we manage external IRB studies?

Due to recent changes with the eIRB+ system, Study Tracker will not be receiving updated APLs for those studies using Central IRBs. Because this information will not be available via the electronic IRB system, PIs and one delegate must manage authorized lists in Study Tracker. Users must be added and also removed when they should no longer have access. This feature is only applicable for Central IRB studies with a external IRB status in eIRB+. 

The PI will be the only Study Team Member automatically granted access to a study. All access to a study begins with the PI. The PI may assign one user with admin rights to manage the addition/deletion of users androles; only the PI and/or the assigned admin may make Authorized Personnel changes/additions to the Study Team Member list. Users will only autopopulate for additions to the APL if their CITI Training completion has been recorded with NU IRB.

To add study team members to your CIRB Study within Study Tracker, please follow these steps: 

  1. After opening your CIRB study, click on the "Settings" tab and locate the "Authorized Personnel" option.
  2. After clicking on the "Authorized Personnel" tab you (PI or delegate only) will find the green "Add" button; click on it. 
  3. In the field box next to "User," you can begin to type in the team member's netID or their last name. Once their name has auto-populated, you may click on it so that it registers in the field. 
  4. Next to the "Title" field box, type the team member's role (e.g., study team member, co-investigator).
  5. Click the green "Done" button and repeat for other team members.

 What is the Study Participant Research Voucher and when is it necessary?

The electronic Study Participant Research Voucher (eSPRV) is a form that must be submitted by close of business the same day a study participant receives medical services at NMH, NMG or NMLF. The eSPRV 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 an eSPRV; 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 an eSPRV created 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 "Medical Budgets/SPRV Setup" to make sure your study information under the blue "Edit Study Information" button is complete. 
  4. An updated phone number must be listed under your user profile (found by clicking your name at the top-right corner of the screen).

Once you've met these conditions, navigate to "Settings" and "Medical Budgets/SPRV," then click the blue "Edit Budget Services" button to create your budget. You can add services by name or CPT Code. Then, submit to NMHC for approval.

 How do I amend a budget?

Navigate to "Settings," then "Medical Budges/SPRV Setup" to make sure your study information under the blue "Edit Study Information" button is complete. Be sure to alsohave an updated phone number under your user profile (found by clicking your name at the top-right corner of the screen).

After confirming that your study information and phone number are complete, click the blue "Edit Budget Services" button to modify your budget. You will be able to remove services already in your budget by clicking the "X" next to each service. You can also add new services by name or CPT Code.

 How do I delete an eSPRV?

If NMHC has not reviewed the eSPRV and it has a status of "Pending," then it may be deleted by clicking on the red "Delete" button while viewing the eSPRV. 

If it has a status of "Reviewed," it can only be amended. 

When in "Action Required" state, an eSPRV can not be deleted but you can change the state from "Action Required" by attempting to add or remove services to the eSPRV. After you make such a change, the state will change from "Action Required" and you can delete it at that time.

 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>Affiliations. Under the Settings>Recruiting section, make sure the following elements are completed:

  • Would you like to advertise this study on Feinberg websites? Checkbox
  • Public/Lay study description field

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>Recruiting section and uncheck the “Would you like to advertise this study on Feinberg websites?” 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: