Competencies for Australian Academic Clinical Trialists

Well trained investigators and support staff are key to the success of clinical trials, whether commercially or non-commercially sponsored. To support the training of staff involved in the conduct and oversight of clinical trials, we developed core competencies for Australian Academic Clinical Trialists (the Competencies).

The Competencies are intended to be used in the development of detailed curricula and training courses by universities, Colleges and other registered training organisations. The intended audience for the Competencies includes undergraduate and post-graduate students as well as individuals undertaking on-the-job training or continuing professional development. 

The Competencies recognise distinctions between commercially-sponsored and non-commercially sponsored clinical trials; however they are not exclusively intended for ‘academic’ clinical trialists. Rather, courses developed on the basis of the competencies should equip students and individuals with the knowledge and skills appropriate for their role on a clinical trial and the nature of the trial. The degree to which courses (or individual modules) focus on matters specific to, for example, a non-commercial, comparative study or a non-drug trial will be a matter for training providers, having regard to the Competencies as a whole.

The Competencies align with other international work in this space.

Please note: the term ‘principal investigator’ referenced in the document may be a single individual, however, when applied to an academic clinical trials context it can be a team of researchers working alongside a project manager.

* Please note that the name of the Clinical Trial Exemption (CTX) scheme changed to the Clinical Trial Approval (CTA) scheme in 2020. This change was instigated to more accurately reflect the nature of the scheme under the Therapeutic Goods Act 1989. References in linked documents or modules to CTX should now be interpreted as references to CTA.