Monitoring

The act of overseeing the progress of a clinical trial, and of ensuring it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s), TGA: ICH Guideline for Good Clinical Practice.

Who is responsible for monitoring activities?

The institution named as trial Sponsor, the Sponsor-Investigator, approving HREC and local Research Governance Office, all have responsibilities for monitoring an investigator-initiated trial.  

The institution named as Sponsor is also responsible for monitoring the trial in terms of the trial’s sponsorship approval, see Institutional Sponsorship for guidance and tools.  

The Sponsor-Investigator is responsible for ensuring their trial is adequately monitored. This activity may be performed by a trained member of the Sponsor-Investigator’s trial team or outsourced to an external Monitor, see Monitoring Trial Conduct and Safety Monitoring for guidance and tools.

The approving HREC is responsible for assessing whether the ongoing safety monitoring plans are being followed and where necessary, adapted to take into account any changes to the safety of participants as the trial progresses.  

The local Research Governance Office is responsible for monitoring the site specific authorisation in light of local safety reports received and the conduct of the trial by the site Principal Investigator and their trial team.  

National guidelines