What is it?
It is a tool created to enable researchers to “track” subject enrollment numbers for clinical research studies. The e-Tracker is linked to the Institutional Review Board Information System or IRBIS and it was created in part by the Office of Research Information Systems and the NC TraCS Biomedical Informatics Core.
Why should I use it?
• It helps you keep up with your enrollment by “visualizing” your timelines better
• Sponsors are more likely to fund future research projects at UNC if recruitment metrics show satisfactory results
• If enrollment is lagging, you can seek timely assistance through the NC TraCS Research Recruitment Office (RRO)
How the e-Tracker helps you:
• Access the e-Tracker anytime, anywhere
• Update enrollment information in real time
• Information is stored securely
Do I have access to it?
If you are a Principal Investigator or Coordinator with an approved IRB study, you can access the e-Tracker.
How do I access it?
Go to the following link and login with your UNC onyen: https://irbis.unc.edu/ct_enrollment/
What if I need help with recruitment?
Contact the NC TraCS Central Coordinator at 919.966.6022 or firstname.lastname@example.org. The RRO will be happy to develop a recruitment action plan for you (or review your existing one) to help you get back on track!
What do the regulations say about research subject recruitment?
(ICH Guidelines E6 Section 4.2.1)
“The investigator should be able to demonstrate (e.g. based on retrospective data) a potential for recruiting the required number of suitable subjects within the agreed recruitment period.”
Importance of meeting targeted enrollment goals
Reaching targeted enrollment numbers is one of the greatest challenges for many investigative sites. At the investigative site level, payment for conducting a study is often directly linked to the number of subjects enrolled. Consequently, low enrollment leaves sites without full payment for the study as originally budgeted, resulting in insufficient funds to maintain study staff.
The NC TraCS Institute is the academic home of the NIH Clinical and Translational Science Awards (CTSA) at the University of North Carolina at Chapel Hill. For more information about NC TraCS programs and services, call us at 919.966.6022, email us at email@example.com, or visit us online at tracs.unc.edu.