The following procedures are related to changes to be assessed by the CCMO Central Committee on Research involving Human Subjects (Central Committee on Research involving Human Subjects ).

The procedures related to amendments to be reviewed by the CCMO can be found here: CCMO-modifications-research-file-amendments.

For the procedures related to amendments of studies submitted under Regulation (EU) No 536/2014 (CTR) see the CCMO website (amendments).