Online Clinical Trial Notification process for CAHS

Commercially sponsored projects

The sponsor is responsible for drafting and submitting the Clinical Trial Notification (CTN) to the Therapeutic Goods Administration (TGA), as well as payment of the fee. CTN submission cannot occur until HREC and institutional approval letters are provided to the local investigator. The sponsor may request information regarding PI, approving HREC and approving Authority details from the local PI to include in the CTN – please refer to Applying to HREC for information regarding HREC and Approving Authority details.

At the time the CTN is lodged with the TGA an email confirmation should be provided to the CAHS RGO via email.

Collaborative Research Group (CRG) projects where CRG is sponsor

The CRG, as sponsor, is responsible for drafting and submitting the CTN, as well as payment of the fee. CTN submission cannot occur until HREC and institutional approval letters are provided to the local investigator. The CRG may request information regarding PI, approving HREC and approving Authority details from the local PI to include in the on-line CTN – please refer to Applying to HREC for information regarding HREC and Approving Authority details.

At the time the CTN is lodged with the TGA an email confirmation should be provided to the CAHS RGO via email.

Investigator Initiated and CRG projects where CAHS is sponsor

When preparing a submission for CAHS HREC and/or CAHS RGO researchers should draft the required CTN on the on-line system. Please contact the RGO if you do not have access to the TGA Business Services system – you will be provided with ‘Drafter’ access under the CAHS Client ID (please see further information about system roles below). A link to TGA guidance for the on-line system is also provided below as well information regarding generic items to be included in the draft.

Once the project is approved, the RGO will submit the CTN to the TGA via the on-line system. The TGA will generate an invoice – the CTN is not processed by the TGA until payment has been received. This invoice will be provided to the investigator by the RGO for payment to be organised. Once the investigator receives acknowledgement from the TGA that the CTN has been processed and is in place this should be forwarded to the RGO for its records. Site approval letters will not be provided to investigators by the CAHS RGO until payment of the TGA fee has occurred and the TGA acknowledgement provided.

Projects where HREC review occurs outside CAHS/PCH, Governance only at CAHS

Where a project is not reviewed by the CAHS HREC but is taking place at CAHS, the commercial sponsor or the institution acting as the sponsor may lodge the form directly with the TGA.Once the CTN Acknowledgement has been received from the TGA, the Investigator must submit this to CAHS RGO via the Research Governance Service (RGS) as part of their application. Site approval will not be provided until the acknowledgement has been received.

Information and Links

• Explanation of User roles within the online system
• Completing the online CTN form | Therapeutic Goods Administration (TGA)

CAHS Information to include

Please include the following information for generic items when drafting the CTN.