Posted by Michael Wonder on 26 Oct 2021
Generating high quality evidence from registry based studies
26 October 2021 - EMA has published guidance to provide key methods and good regulatory practices to pharmaceutical organisations on the planning and conduct of registry based studies.
A patient registry is an organised system that collects uniform data over time on patients who are diagnosed with a particular disease or condition, or who receive particular medicines.
A registry based study is a clinical trial or a non-interventional study that investigates a research question using the data collection infrastructure or the patient population of one or several patient registries.
