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Pivotal Study Requirements

I. CME Course

• Complete the continuing medical education (CME) course.
  1. Create an account in the FDA CE portal
  2. Click on “Online Learning” tab
  3. 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• The training materials from our pilot study have been archived here for reference.

Created on 19 Jan 2023, Last modified on 24 Mar 2023