If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master PICF or investigator brochure, DSUR, ASR), the submission will be reviewed on behalf of all Bellberry approved sites. In the event the submission does not apply to all of these sites, the submitting site must provide an explanation. Please refer to MAR F1.1.3 amendment pathways flowchart for further information.
Amendments and safety reporting
