Important changes to the Clinical Trial Notifications (CTN) submission process

As of the 1^st July 2015, the Therapeutic Goods Administration (TGA) has introduced a new online system for submitting Clinical Trial Notification (CTN) forms, and hard copy applications will no longer be accepted. The TGA also advised that any paper based forms that they receive after the 30^th of June 2015 must be also submitted online via the new portal. In an attempt to streamline the submission process, the online system no longer requires signatures but rather a declaration by the sponsor upon submission of the CTN.

While this may ultimately enhance the efficiency of governance aspects of clinical trials in Australia, the change was not widely consulted and was released without warning. To date, users have been experiencing significant problems with the system and as such, access to the TGA online portal at Monash is currently restricted to the staff in the Human Ethics Office who will be the key contact point between you, the researchers, and the TGA.

We have prepared the MUHREC Clinical Trial Details form (CTD), a dynamic PDF version of the new CTN form to capture the required information, which we will then enter and submit on your behalf. We will forward relevant information from the TGA to you. We will also process the required payment online and we will credit the amount to your nominated cost centre and fund number.

The form and submission requirements are now available at the MUHREC clinical trials webpage.

If you have any queries about the new process, please email muhrec@monash.edu or call me on 99052052.