[Holly]

Hi Amie – this is absolutely spot on, and allows for effective use of retrospective studies for the purpose of PMCF that do not require EU oversight or prior ethics committee approval (there are of course limitations to this, but thats generally the case in most scenarios). The study does not impact clinical management of the patient, so the primary concern becomes data privacy and ensuring GDPR compliance.

Retrospective clinical studies is an incredibly robust tool to obtain real world evidence and satisfy some of the clinical evidence requirements!