Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to reflect the NHRMC’s serious breach questions. Sites may complete these questions, or upload MAR F3.1.1 Serious breaches report form – sponsor or MAR F3.1.2 Serious breaches report form – third party, as applicable.
Please note, the acknowledgement letter will code the item as ‘PVR’; this is system-generated and cannot be altered.