Clinical Research Development Office (CRDO) resources
Clinical trials that use an unapproved therapeutic good or use an approved therapeutic outside the conditions of its registration must submit a CTN notifying the TGA.
Trials require evidence of CTN submission prior to receiving Royal Children's Hospital (RCH) governance approval. We recommend you begin your CTN draft when you submit your study for ethics approval.
Please submit the Clinical Trials Notification request form if you need to organise a CTN. You should anticipate a minimum of 2-3 weeks for your CTN to be fully processed.
To make CTN variations, please submit the CTN Variation submission form. A CTN variation is necessary for any changes to the study such as changes in PI, changes in expected trial completion dates, new sites added, additional medications or changes to drug administration etc.
A CTN is required as a part of your Governance Submission regulatory documents. Regulatory documents refer to those necessary for reporting the conduct of drug and device trials to the government. For more information, see below.