CCMO Central Committee on Research involving Human Subjects (Central Committee on Research involving Human Subjects )
For a study submitted under Regulation (EU) No 536/2014 (CTR), SUSAR Suspected Unexpected Serious Adverse Reaction (Suspected Unexpected Serious Adverse Reaction)'s must be reported through Eudravigilance and no longer need to be submitted directly to the CCMO. For more information see the CCMO website - Safety reporting (link is external).