Pivotal Study Requirements
I. CME Course
- Complete the continuing medical education (CME) course.
- Create an account in the FDA CE portal
- Click on “Online Learning” tab
- Scroll down to our course: “Assessment of Stromal Tumor-Infiltrating Lymphocytes”
- You can also use the search function on the “Online Learning” page to search for “Assessment”..
Mirror of the CME course
- Here is a link to course materials available outside of the official CME course delivery platform.
- Email your CME completion certificate to Brandon Gallas (brandon.gallas@fda.hhs.gov).
II. Interactive Training
- After completion of the CME course materials, you must complete the Proficiency Test on the sTILs assessment to continue with the Pivotal Study
- Instructions will be provided in response from Brandon Gallas to your CME completion certificate.
- Link to the Interactive Training can be found here
- After completion of the Proficiency Test, email Brandon Gallas (brandon.gallas@fda.hhs.gov), so your annotations can be assessed.
~Archived~ Pilot Study Training Materials
- The training materials from our pilot study have been archived here for reference.