Writing the Clinical Study Report Trailer
Diagnostic studies vary greatly from standard pharma and device studies, and the documents generated for these studies differ accordingly. This web seminar presents the basic tools required to generate Clinical Study Reports (CSRs) for sample collection, accuracy, and reproducibility studies. Participants will learn the elements of each of these CSRs, the guidances to follow for reference, basic skills for understanding the data (i.e., false positives, false negatives, and percent agreement), and other diagnostics output and results, as well as coordination with the 510(k) submission.