Title: - Standard Operating Procedure (SOP) Monitoring Visit Activities for Clinical Trials of Investigational Products

The purpose of clinical trial monitoring is to verify that: • The Investigator is conducting the study in accordance with the protocol, Good Clinical Practice (GCP) guidelines and applicable regulatory requirements; • The Investigator and members of the study team are appropriately trained and supported to complete their role in the study; • The participant’s safety, rights and well-being are prot. [...] Date of consent correlates with a visit date, either before or on the day of the first study- related activity SDV and CRF review The percentage of SDV and CRF review to be completed for each trial is determined by risk assessment of the trial and the trial team experience and should be documented in the study- specific Clinical Monitoring Plan. [...] This includes the following tasks: • Verify that the PI and site personnel are adhering to the protocol and conducting the study within the conditions of the HREC approval and according to regulatory requirements and GCP. [...] Close-Out Visit Preparation The Monitor will confirm with the trial team and the Sponsor-Investigator, the scope, format and anticipated duration of the close-out visit and schedule the time. [...] On Campus, The Royal Children's Hospital is the custodian of clinical care, The Murdoch Children’s Research Institute is the custodian of research and the University of Melbourne is the custodian of education.