As of the 1st 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 30th 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.
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