After Ethics and Governance Approval

Once the reviewing Human Research Ethics Committee (HREC) is satisfied that the trial protocol and any written documents provided to participants meet their requirements, they will issue the Sponsor-Investigator with the ethics approval letter. 

If it is a multi-site study that has been reviewed under the NMA scheme, the approval letter will list all the sites included in the approval.  

Responsibilities of the Sponsor-Investigator

• Notify all participating sites (if a multi-site study) that the trial is approved and forward them the approval letter
• Arrange for the sponsoring institution to submit the Clinical Trial Notification (CTN) or Clinical Trial Exemption (CTX) to the Therapeutic Goods Administration (TGA) (if applicable)

Note that only sites who have received their local governance authorisation can be listed on the CTN. If any individual site is facing a delay in their governance authorisation, the Sponsor-Investigator can decide to proceed with submitting the CTN without that site and add them later as a variation. The trial budget may have an impact on this decision because each time a variation is submitted, an additional fee is charged.  

• Trial registration – update the HREC approval status from pending to approved and update the overall recruitment status to Recruiting. The recruitment status of individual sites can be updated once they have local governance authorisation
• Arrange for investigational medicinal product or investigational medical device (if applicable) to be delivered to each site. This should not occur until the TGA has acknowledged the CTN/CTX.

Responsibilities of the Site Principal Investigator

• Forward the ethics approval letter to site’s local research governance office and complete all activities required for the site authorisation process, see Ethics and Governance Application Process
• Ensure delegation of Investigator responsibilities to appropriate members of the trial team who have the appropriate qualification for their role, have undertaken GCP training within the last three years and have undertaken any training relevant to their role in the trial
• Ensure a delegation of duties log has been completed that includes name of person, their role (eg Study Coordinator, Data Manager) and the activities they have been delegated by the Principal Investigator

For further information and an example delegation of duties log template, see the guidance and template available from the Forms section of the Society for Clinical Research Sites (SCRS) website.