Implementation of Clinical Trials Regulation EU no 536/2014 to Clinical Operations -organisation's working procedures

New Clinical Trials Regulation EU no 536/2014 (EU CTR) will be implemented fully in European Union in January 2022. New regulation will introduce major changes in a way clinical trials are conducted in EU area. Organisations conducting clinical trials need to be prepared for the changes the new regulation will bring. The purpose of this qualitative study was to support implementation of Clinical Trial Regulation to Company X operational procedures. The objective was to find out how should Company X Clinical Operations Finland -organisation amend their working procedures to meet the new regulation requirements. Focus was identified to be in start-up process of the trial. This study used PDCA (Plan, Do, Check, Act) approach as this model is used to embedding the continuous improvement in organisations. Purposive data sampling was used. Data for this study was collected by interviewing five experts on trial start-up process at Company X. Data collected was analyzed by using deductive content analysis. As expected, results showed that there are operational procedures that are impacted when new regulation enters into force. Certain tasks currently done will be diminished at country level as clinical trial submission will be done centrally for all participating EU countries. Some tasks will remain the same but new regulation is setting stricter timelines while some tasks are not affected at all. The results lead to the conclusion that there are certain working procedures that should be improved to better meet the requirements from new regulation. These procedures rely mostly on submission document preparation