Trial Master File – Table of Contents Document Filing Guideline - Section Contents Document Filing Guideline / Available Templates 1.0 Central Trial Coordination Team

Documents to be filed in this Section include: TGA Acknowledgement Clinical Trial • Copy of the CTN Acknowledgement listing all participating sites – current and superseded 5.2 Notification (CTN) or Clinical Trial • Copy of the CTX Acknowledgement listing all Exemption (CTX) participating sites – current and superseded Documents to be filed in this Section include: • Copy of the electronic CTN Sub. [...] 6.0 Sponsorship 6.1 Sponsor Authorisation Letter Documents to be filed in this Section include: • A copy of the MCRI Certificate of Sponsorship • Subsequent copies of MCRI Certificates of Sponsorship 6.2 Completed Risk Documents to be filed in this Section include: Assessment/Management Tool • A copy of the completed MCRI Sponsorship Application including completed Risk Management Table • Copies o. [...] 12.5 Database Management Documents to be filed in this Section include: Documentation • Database Specifications • DB Specification • Database Review and Testing Log • DB Testing • Database Version Tracking Log – to be completed by the Database Manager (if • Database Version Tracker applicable) or Trial Coordinator to track the history of the database and any subsequent amendments to the database. [...] The members of the DSMC must sign the charter to indicate their approval of the content and agreement to adhere to the terms of the charter. [...] 19.0 Other Communication 19.1 Newsletters to Sites Documents to be filed in this Section include: • Copies of Newsletters sent to participating sites 19.2 Other General Correspondence Documents to be filed in this Section include: • Other significant general correspondence 20.0 Publications/Abstracts 20.1 Publications Documents to be filed in this Section include: • Copies of accepted publications.