Digital technology for clinical trial research agreements


Guiding principles on optimising digital technology for executing clinical trial research agreements (CTRAs) using eSignatures has been released in a new position statement - Electronic signatures and clinical trial research agreement execution in Australia.

State and Territory Government departments, as well as public health institutions and sponsors, are called upon to establish policies and procedures to facilitate CTRAs execution using electronic or digital signatures to reduce delays to commencing a clinical trial and costs.

CT:IQ, together with AusBiotech, Medicines Australia (MA), and the Medical Technology Association of Australia (MTAA), has released a joint position statement confirming that eSignatures can be used to execute CTRAs in Australia.

Benefits of utilising eSignatures include reduced delays for CTRA execution, reduced costs, enhanced security and the ability to accommodate government-directed requirements and Safe Work principles, by reducing the risks to staff associated with wet-ink signatures. The use of electronic signatures or processes to facilitate business transactions has been legal in Australia since 1999.

AusBiotech recognises the importance of clinical trials in research and development and has been advocating for more than ten years for a more effective environment within Australia. Clinical trials play a pivotal role in creating life-saving and life-enhancing treatments for patients in need and provides substantial economic benefits through inbound investment, job creation, and skill development.

Australia has been amongst the globe’s lesser COVID-19-impacted countries, providing the opportunity to start and continue clinical trials and medical research through the pandemic. Optimising digital technology such as eSignatures will strengthen the sector even further.

Read the joint position statement in full.