Core competencies for Australian academic clinical trialists

NHMRC has released new guidance on Core Competencies for Australian academic clinical trialists

Intended for use in development of detailed curricula and training courses by universities, colleges and other registered training organisations, the Competencies are relevant to audiences including undergraduate and post-graduate students, and individuals undertaking on-the-job training or continuing professional development.

The Competencies focus on seven core areas, each including detailed criteria for demonstrating proficiency and the level of ability required, depending on the person’s role in the clinical trial. They are intended to be used when developing or implementing education programs relating to the conduct of clinical trials and are consistent with a framework developed for commercially sponsored studies by the Clinical Trials Transformation Initiative and Transcelerate Biopharma, and other international work in this space.

NHMRC encourages us to consider how the Competencies can be incorporated into educational materials and courses and emphasises that modification of the Competencies may be necessary for alignment with specific practice areas. For example, while the term ‘principal investigator’ referenced in the document may be a single individual in some trials, when applied to an academic clinical trials context, it may be a team of researchers working alongside a project manager.

The Competencies are available on the NHMRC website and can be used and adapted as appropriate.

If you have questions about the Competencies contact NHMRC Ethics and Integrity section