The roles and functions of the positions and groups involved in conducting clinical trials are provided as guidance for health service organisations to establish or continue to deliver clinical trial services. Health service organisations or trial sites may also consider these roles and functions to assist in coordinating the tasks between the governing bodies, workforce, patients, consumers and trial sponsors.
For larger organisations, dividing up the responsibilities amongst these different roles can increase the speed and efficiency of trial processes. For smaller organisations, some roles may be merged. The health service organisation may implement roles, systems and processes in consideration of their local needs, values and the context in which services are provided.
The roles and functions of positions and groups that a health service organisation should establish to deliver clinical trials (either investigator-initiated or externally sponsored) follow.
