In Part 1 of our IVD Deep Dive series, we discussed the importance of selecting meaningful performance objectives and explained how these objectives help establish the acceptance criteria. Part 2 of our series will pick up from there with strategies to identify sources of clinical data for your IVD.
Do you have questions about how to generate, collect, analyze, or assess clinical data? Are you concerned about clinical data sufficiency? This webinar will present tips to help you identify sources of clinical data and discuss how to organize these data within the Clinical Performance Report.
|March 30th, 2022||Watch at a convenient time||Virtual|
Based on the state of the art:
Discuss the purpose of the CPR and its role as a critical component of the PER
Identify sources of clinical data and analyze those data within the context of the performance endpoints and acceptance criteria presented in the SVR
Demonstrate how to extract, organize, and appraise these data within the CPR