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”.
- Link to “mirror” of the CME course. This mirror includes course materials available outside of the official CME course delivery platform.
To participate in the HTT Pivotal Study, email your CME completion certificate to Brandon Gallas (brandon.gallas@fda.hhs.gov).
II. Interactive Training
- To participate in the HTT Pivotal Study, you must complete the Proficiency Test on the sTILs assessment.
- Visit this link to get started on the interactive training.
- After completion of the Proficiency Test, email Brandon Gallas (brandon.gallas@fda.hhs.gov), so your annotations can be assessed.