The Sponsor-Investigator is responsible for oversight of their Investigator-initiated trial (IIT), including the conduct of the trial by all members of the research team across all participating sites.
The Sponsor-Investigator is responsible for monitoring the trial to verify that:
For guidance about monitoring safety of participants:
Monitoring the conduct of the trial, including the data collected, is essential to have confidence that your analysis is robust, will support your research question and stand up to critique from your peers. Your data needs to be reliable as it may be used to inform clinical practice, inform further research or in some cases, support the development of a new medicine or medical device.
Institutions should have standard operating procedures, guidelines and templates to help the Sponsor-Investigator and their research team to monitor the conduct of the trial. This includes monitoring the lead site and any external participating sites.
See the MCRI: SOP Monitoring Visit Activities for Clinical Trials of Investigational Products for an example.
Sponsor-investigators and their teams should use a risk-based approach to monitoring their trials. Monitoring should have a risk-based approach and focus on critical data and processes. Particular attention should be given to those aspects that are not routine clinical practice and require additional training.
When developing the trial-specific Risk Assessment and Management Plan during the trial planning stage, the Study Investigator will establish the extent and nature of monitoring required for the trial. This information should then be incorporated into the trial-specific Clinical Monitoring Plan.
Monitoring options include on-site, remote, centralised or a combination of the three, see Different Ways to Monitor Clinical Trials to understand the different types of monitoring so you can write your monitoring plan.
The monitor must follow the trial-specific Clinical Monitoring Plan. They would usually review the following items at a monitoring visit:
More details about what is involved in these activities can be found in the MCRI: SOP Monitoring Visit Activities for Clinical Trials of Investigational Products.
The monitor must complete a Monitoring Visit Report each time a monitoring visit is conducted. Remote and centralised monitoring activities also need to be documented and reported to the Sponsor-Investigator on a regular basis.
It is important that monitoring activities are documented so there is a record of the activities conducted and the information obtained is available for reporting to stakeholders including the Sponsor-Investigator, approving HREC, local Research Governance Office, Principal Investigators and the Therapeutic Goods Administration (TGA), if applicable.
Monitoring Visit Reports, when used consistently and regularly, can serve as documented evidence in an audit or regulatory inspection to measure Sponsor-Investigator oversight and the culture of safety and quality within the trial team.
