Migration of Clinical Trial Notifications (CTNs) from paper-based database to new online system

29 April 2016

The TGA anticipates that migration of previously notified trials will be complete by 30 June 2016. The transition form will no longer be available after this date. All trials that have not been migrated will be archived by the TGA. Steps to ensure your trials are migrated before this time:

  1. Ensure that your organisation has online access to TGA Business Services (TBS) and that your organisation does not have duplicate TGA client IDs.
  2. Nominate an administrator and update organisation details via the Organisation details form. Ensure all users have appropriate system user roles and access.
  3. Communicate administrator contact details to the clinical trials team via an email to .
  4. The clinical trials team will contact the administrator and provide a list of trials to be migrated to your organisation's online portal.
  5. The administrator should then reply to the clinical trials team to confirm the organisation's TGA client ID and the list of trials to be migrated. Please note this communication may be to close any inactive trials if necessary.
  6. Once the CTN information is posted to the TBS system you will then be able to view and vary CTN information in the TBS system.

Migration

On 19 October 2015, the TGA began migrating CTN information from trials that were notified via the paper-based system to the online TBS system. Once completed, this will allow sponsors to use the TBS system to view and change active CTNs that were notified before 1 July 2015.

The migration process has been set out in the stages below. Stages 1 and 2 have now been completed.

diagram showing the proposed migration process

Stage 1. Closing the paper-based database

On 19 October 2015 the internal paper-based database was closed. The TGA can no longer process paper based CTN or completion advice forms. Please make sure you have confirmed migration of your organisations trials as outlined above.

Stage 2. Re-formatting data

The TGA re-formatted data from the old paper-based database to allow matching of data fields to the new online form. During the data re-formatting period, the TGA was able to include changes notified using the Transition Form. Such changes will be reflected in the online system.

Stage 3. Posting data to the online format

Beginning 7 December 2015, the TGA began posting CTN data from pre-1 July 2015 CTN forms once individual sponsors had confirmed their TBS Client ID and list of trials to migrate. The TGA is posting data to the online system based on matching client IDs. It is important that sponsors who have changed Client ID notify the clinical trials team via email () of any such changes.

Once the CTN information is posted to the TBS system you will then be able to view and vary CTN information in the TBS system. TGA will update the TGA website advising of the completion of migration. The Transition Form will no longer be available once data migration has been completed.

Post migration

Sponsors may need to update data for new fields in the online system once previously notified CTNs have been migrated, for example email addresses, information about a medicine's presentation or medical device details that were previously captured in free-text fields.

Background

On 1 July 2015, the TGA introduced a new online form for the CTN scheme that allows CTN forms to be submitted electronically through the TGA Business Services (TBS) portal.

The new online system replaced a paper-based form which required four signatories (sponsor, approving authority, human research ethics committee and principal investigator).

Contact us for advice

You can get advice from the TGA regarding the clinical trial notification scheme via: