The sponsor must be an Australian entity
Clinical trials can be sponsored by:
- individuals (for example, medical practitioners)
- bodies and organisations (for example, hospitals, Area Health Services, non-government organisations)
- companies (for example, pharmaceutical companies).
The type of sponsor will vary from trial to trial, depending on who takes overall responsibility for the conduct of the trial.
The sponsor usually initiates, organises and supports a clinical
study, and carries the medico-legal responsibility associated with the
conduct of the trial.
If the investigator initiates and organises the trial, he or she is
to be defined as the sponsor of the trial and will be responsible for
the sponsor's functions. This includes, for example, where another party
(usually a pharmaceutical company) provides the medicinal product used
in the clinical trial, but has no other involvement in the conduct of
the trial."