===Year 3: High-throughput truthing of microscope slides to validate artificial intelligence algorithms analyzing digital scans of pathology slides: data collection to create the medical device development tool (MDDT)=== In Year 3 of the High Throughput Truthing project, the team will collect data at various collaborating sites and conferences. [[BR]] Check out our completed work from [HighThroughputTruthingYear1 Year 1] and [HighThroughputTruthingYear2 Year 2] in the HTT project [[BR]] * [https://ncihub.org/groups/eedapstudies/wiki/HTTdataCollectionTraining/File:20200928_HTT_recruitPathologists-v1.pdf Link to pathologist recruiting advertisement] * Research collaboration agreement scope for collaborators providing slides and other materials * [[File(CDRH_RCA_Gallas_Template_7-23-2020.doc)]] '''Pitch:''':: We are crowdsourcing pathologists to collect data (images + pathologist annotations) that can be qualified by the FDA/CDRH medical device development tool program (MDDT). If successful, the MDDT qualified data along with a statistical software package for data analysis would be available to any algorithm developer to be used to validate their algorithm performance in a submission to the FDA/CDRH. Researchers from the U.S. Food and Drug Administration, alongside academic collaborators, are collecting pathologist annotations as data for AI/ML algorithm validation for tumor infiltrating lymphocyte (TIL) detection and quantitation. We are asking board-certified anatomic pathologists and anatomic pathology residents to score 80 ROIs as part of a research study. We anticipate that this task will take participants a total of 30 minutes. The data are intended to inform the agency’s approach to novel algorithm validation, ensuring high quality commercial products with a faster FDA-pipeline to approval. [[BR]] [[BR]] ===[HTTdataCollectionTraining Complete the HTT Data Collection Training]=== __Consent Form:__ [[BR]] [[File(HTT_IRBinformedConsent.pdf)]] ===[HTTstartDataCollection Begin Data Collection]=== __Exit Survey:__ [[BR]] Please complete [https://docs.google.com/forms/d/e/1FAIpQLScRhtEN7cudrG3-0eauke1Dg_9JySpANK0mj3dRqk7c15WN6w/viewform this Survey] when you finish data collection, and help us improve the HTT project. __Get Involved:__ [[BR]] * Supply glass slides and their scanned versions * Help create a Continuing Medical Education course in conjunction with this project * Host an analog (microscope + eeDAP) data collection event at your clinical site * Help spread the word, recruit your colleagues to participate in online data collection __Thank you. For more information contact:__ [[BR]] '''Brandon Gallas''', !PhD, ([mailto:brandon.gallas@fda.hhs.gov brandon.gallas@fda.hhs.gov]) [[BR]] FDA/CDRH/OSEL Division of Imaging, Diagnostics, and Software Reliability [[BR]] on behalf of the High-Throughput Truthing (HTT) Project