Post Authorisation Notification2024-06-12T01:51:15+00:00

Post Authorisation Notification 

HREC Amendments that impact the site activities or changes to the protocol or participant information sheet need to also be submitted to the research governance office via ERM as a post-authorisation notification.  

Changes to associate investigators that do not impact the study or transfer of data do not require governance approval; these changes can be managed via the study delegation log.  

At a minimum the following is required  

  • Detailed covering letter explaining the rationale for changes to the study and study documents.  
  • Ensure that all documents have document identifiers in the footers, i.e. version numbers, dates and page numbers 
  • Please complete the relevant fee template and submit with your application.   

More information on fees.

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