Important considerations before submitting a trial for registration with ANZCTR
Are you responsible or authorised to register a trial?
Only the trial's primary sponsor or their authorised representative should register
the trial. If, for example, you are the site manager of a multi-centre trial, you
should not register the trial - the trial's lead investigator, primary sponsor or
overall trial coordinator should register the trial. Please contact the person responsible
for the trial's overall management to check if you are authorised to register the
trial before proceeding further.
Click here for more information on trial
sponsors.
Has the study already been registered on ANZCTR?
Your trial should only be registered once on the ANZCTR. Please check that the trial
has not already been registered on the ANZCTR by searching the ANZCTR database before proceeding further.
Note: Preferably, a trial should be registered on only one Registry, but
registering with more than one Registry is possible if required by an ethics committee
or other regulatory body.
Is there a more appropriate Primary Registry in the WHO Registry Network for you
to register the trial with?
Before submitting your trial for registration with ANZCTR you should consider if
there is a more appropriate registry. For example, if you are a researcher based
in China and your trial is going to be conducted in China, it would be more appropriate
for you to register your trial on the Chinese Clinical Trial Registry (ChiCTR).
Click here
to see the full list of Primary Registries in the WHO Registry Network.
Is the trial eligible for prospective registration?
In order to obtain prospective registration, the registration process must be completed and the trial must have a trial registration number (ACTRN) issued before enrolment of the first participant.
Steps in registering a study with ANZCTR
Click here
to see the summary flowchart of trial registration process with ANZCTR.
1. Ensure that you have read the Important
considerations before submitting a trial for registration with ANZCTR section,
Privacy policy and Terms and conditions.
2. First time user? If so, apply for a user account here. If you already have an account, proceed to step 3.
To register a trial you will need to be a registered user with a unique login. You
only need to do this once, and can register as many trials as you wish. You can
apply for new user login online by completing details regarding your name and professional
contact details including your telephone number, email address and relevant affiliation
(e.g. institution or collaborative research group).
Choose a password you can remember, and click "Submit".
Note: User applications are processed and are not instantaneous.
3. Click on the ‘REGISTER YOUR TRIAL’ button on the right hand panel of the home
page
You will then be prompted to login to your user account.
4. Complete the ANZCTR registration form
You will then be directed to the data fields you need to complete. You are encouraged
to complete all the fields if possible. Mandatory data fields are highlighted in
bold and marked with an asterisk, and are based on the requirements for registration
of the World Health Organization (WHO) and International Committee of Medical Journal
Editors (ICMJE). Data should be saved frequently by clicking on the ‘Save details’
button or ‘Next step’ button present on the top and bottom of the page. If you need
to logout and return later to complete your submission, your data will be saved.
Resources for completing the ANZCTR registration form.
- ANZCTR form data definitions (PDF)
- Hints and instructions for items to be addressed and corrected before submission
(PDF)
- 'How-to' videos for steps of registration: Step 3: Intervention, Step 4: Outcomes, Step 11: Data sharing
5. Review and submit the registration form
Once you have filled in all the required data fields you will be asked to review
your data to ensure they are suitable for submission. If all the required fields
have been completed correctly, you will then need to click on the ‘SUBMIT’ button
to submit your record for review by ANZCTR staff. You should receive an
on-screen message and email confirming that the record was successfully submitted.
6. ANZCTR staff review submission
Your submission will be checked by ANZCTR staff. If more information is required
before your trial can be registered, we will send you queries via email. It is important
that you promptly address these queries to ensure timely registration of your trial.
Following satisfactory verification of the record, each trial is allocated a unique
registration number (ACTRN). This record is then publicly viewable.