Describes a risk-based approach organisations may use to determine if they are willing to sponsor an investigator-initiated trial. Successful applications will be issued with a Certificate of Sponsorship (signed by a representative of the committee and the Sponsor-Investigator) that outlines the tasks that the sponsoring institution has delegated to the Sponsor-Investigator as a condition of sponsorship.
In this example, a committee reviews each application for sponsorship, the application occurs in parallel with the ethics application review by the ethics committee.
Note: The Certificate of Sponsorship form that supports this SOP