Protocol Accrual Tracking System (PATS)
PATS is a Web-based application for tracking, editing, and reporting human subject enrollment on Consortium studies. PATS is designed to meet NCI human subject accrual reporting requirements by collecting study data from the partner institutions on an ongoing basis. Minimal demographic information such as ethnicity, race, age, gender, and disease site will be entered into PATS for each subject for the reporting of summary information to the NCI and other funding agencies.
Criteria for Studies Subject to Enrollment Reporting
Any study subject to the Consortium Protocol Review Requirements (PRR) is also required to report human subject enrollment in PATS. This document describes the criteria. Optionally, enrollment can also be tracked on protocols which are not subject to PRR. PIs and their authorized staff may want to track enrollment for all of their studies in PATS. Questions on this requirement can be directed to Clinical Research Support at 206-667-4520.
Direct Use of PATS v. Form Submittal
You are required to directly enter the subject enrollment into the PATS system within 24 hours of enrollment of the study. If you are unable or the system is unavailable, there is a PATS Research Subject Data Form which you can fax instead.
Consortium investigators and authorized staff will have the ability to report new enrollments, edit existing data, and view online accrual reports by protocol or investigator. Eventually, PATS may tie in with the research data repository to serve investigator needs by facilitating consent tracking, QA functionality, and access to patient records by protocol. While initial functionality will serve to fulfill NCI reporting requirements, the plan is to add system features and functions which will add value to the investigator with improved study management tools.
PATS is accessed through the CORE (Clinical Oncology Research Entrance) secure website. To start PATS, click here.
To enter CORE, you will need a user ID and a password. To request a CORE account, go to the CORE website and click the link near the top of the page to request a new account. If you can already access FYI through CORE, your existing account will be modified to include PATS.