WHAT IS STUDY TRACKER?
Study Tracker is a set of web-based clinical research tools help to improve efficiency, safety, and security for subjects in research studies. The research subject tracking log of Study Tracker is used for all human clinical trials initiated by researchers at Northwestern University and Northwestern Medicine®. All clinical research studies overseen by the NU IRB involving Feinberg School of Medicine faculty, regardless of where performed, are required to record participants in Study Tracker.
HOW MANY CLINICAL TRIALS HAS STUDY TRACKER TRACKED?
NITRO Study Tracker has logged more than 6,000 studies with nearly 80,000 patient accruals. In 2013 alone, there were more than 1500 studies initiated.
HOW MUCH DOES STUDY TRACKER COST AND WHO CAN USE IT?
Study Tracker is a free application. To access Study Tracker, simply log in from an NMHC or NU network using your NetID and password to see the studies for which you have authorization at https://enotis.northwestern.edu/login. This link will not work if you are off site. Please use a VPN for remote access.
HOW DO I GET STARTED WITH STUDY TRACKER?
Your study must be approved in eIRB+ first. If you have any questions, you can send an e-mail to: email@example.com
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 (age, gender, ethnicity, etc.)
- Patient diagnosis information
- Patient consent, withdrawal, and study completion details
- Information about patient research services rendered at partner institutions: blood draws, laboratory workups, imaging, etc.
- Medical Record Numbers (MRNs) from Northwestern affiliates, including Northwestern Memorial HealthCare (NMHC) and Northwestern Memorial Group (NMG)
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 Northwestern Memorial HealthCare (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 (NMEDW) reports.
CAN I USE OTHER SOFTWARE OR RESOURCES WITH STUDY TRACKER? WHAT DO YOU SUGGEST?
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.
- Recruit - This registry platform can help you recruit patients and directly links with Study Tracker to import patient information
- Northwestern Medicine® Enterprise Data Warehouse (NMEDW)
- The Center for Clinical Research provides research study support, including IRB submissions and patient recruitment
- The Clinical Research Units (CRUs) offer patient visit sites
- The Quantitative Methods Group (QMG) 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 research process, including trial design, IRB submission, patient identification and recruitment, software services, and data analysis
Where do I go if I still have questions about Study Tracker?
Check out the Study Tracker FAQ on the NITRO Study Tracker homepage for more detailed information. If you still can’t find the answer to your question, please email firstname.lastname@example.org . Learn more about Study Tracker with one of our upcoming in-person sessions. Register today: Basics & Policy Training Update and New Features Demo Session