Implementation of Regulation (EU) No 536/2014 as a Non-commercial Sponsor: An Internal Survey and a Descriptive Analysis of Timelines.

Based on the results of the retrospective and prospective parts of the study, it is clear that the shorter reply timelines are the main factor that will affect the organisation. EORTC has spent significant resources in adapting its processes to comply with the CTR's new requirements. Experience with the first studies under the new regulation can be utilized to implement further process adaptations.