MCRI Sponsored Investigator Initiated Trials (IITs)
An IIT is a clinical trial which is initiated and organised by an Investigator i.e. an individual rather than a collaborative group, company, or organisation. In these cases, the Investigator will take on the role of the trial sponsor and will then be responsible for the extensive Good Clinical Practice (GCP) guidelines and regulatory requirements associated with both the management and conduct of the trial in the case it is an interventional trial.
Not sure if your research is a trial? Use our MCTC187 Guidance | Clinical Trial Decision Tool. The tool includes case examples of both trials (interventional research) and observational research (non-interventional research).
At Melbourne Children’s, we use the term Sponsor-Investigator to refer to the Investigator leading an MCRI-sponsored IIT. CRDO have developed this toolkit to assist Sponsor-Investigators and their teams understand their responsibilities. The toolkit will link you to the extensive array of resources we have to help you, including Standard Operating Procedures, guidance, protocol templates and relevant training. It also directs you to other MCRI and RCH research support groups that may be able to assist you.
Content will be updated regularly. If you can’t find what you are after, please send your enquiry to [email protected].