Audits

An audit is a systematic and independent examination of trial-related activities and documents to determinewhether the evaluated trial-related activities were conducted, and data were recorded, analysed, and accurately reported according to the protocol, sponsor’s and sites standard operating procedures (SOPs), GCP, and applicable regulatory requirement(s). It is an expectation that trials & research projects are audit-ready at all times.  

Audits can be conducted by your external Sponsor, the local Research Ethics and Governance Office, the Quality Assurance team at Melbourne Children’s, or Regulatory bodies (the TGA, FDA, EMA, etc).  

Your external Sponsor and the Regulatory bodies have their own processes and procedures that they use when conducting audits, and they will share these with you, if and when they are auditing your site. If you are contacted regarding an external audit happening at Melbourne Children’s, please let REG and MCTC know.  

The local Research Ethics and Governance Office and the Quality Assurance team at Melbourne Children’s also have defined processes and procedures for conducting audits, and you can find those here:

·        MCTC199 SOP | Internal Auditing

·        Research Governance and Ethics: Monitoring Program