Electronic Signatures and Clinical Trial Research Agreement execution in Australia
14 September 2020
Release date 12 September 2020
CT:IQ together with Medicines Australia (MA), Medical Technology Association of Australia (MTAA) and AusBiotech have released a joint position statement confirming that eSignatures can be used to execute clinical trial research agreements (CTRAs) in Australia. Read the statement below or access Joint Position Statement [PDF: 236KB]
The use of electronic signatures or processes to facilitate business transactions has been legal in Australia since 1999. This is embodied under the Electronic Transactions Act 1999 (as amended) and the relevant complementary State Acts¹.
Section 10 of the Act outlines the use of electronic signatures (eSignatures² or Digital Signatures³ ) which are deemed equivalent to other forms of signature if the identity and intention of the person signing them can be established.
Executing Clinical Trial Research Agreements (CTRAs)4 using eSignatures optimises digital technology for sponsors and public health organisations and is equivalent to wet ink5 signatures under the Act.
Additional benefits include reduced delays for CTRA execution, reduced costs, enhanced security and the ability to accommodate Government-directed requirements and Safe Work6 principles, by reducing the risks to staff associated with wet-ink signatures.