Changes to the study should be reported in CTIS. Significant changes (SM) are changes that affect the safety and rights of participants, or that may impact data quality. Non-significant changes (NSM) are for information and archiving in CTIS. It is the sponsor’s responsibility to assess whether a change is a SM or an NSM.
For examples of changes in Parts I and II under CTR, see Annex 4 in the Questions and Answers Document.
