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Reporting Amendment Notifications

The Research Governance Officer (RGO) must be notified of all mattes related to your research project, to ensure your study has 'ongonig site authorisation'.

 

Examples of what needs to be reported to the RGO:

  • Updated study documentation (ie. Protocol, investigator brochure, participant information sheets, flyers, etc)
  • Annual / Final Report
  • Annual insurance certificate 
  • CTN acknowledgment letter from the TGA 
  • Change in study personnel (adding / removing members of the study team)
  • Contract amendments 
  • Adverse event reports or SUSAR reports 
  • Closure of study, completion of study, withdrawl of study site, etc 
Note: It is the responsibility of the Principal Investigator to report matters to the RGO and all matters must have first received endorsement by the associated HREC.

Submitting Amendment Notfications to the RGO for NBMLHD based Studies

Complete and submit a Research Governance Amendment Form  together will the HREC approval letter and associated documents to the Research Governance Officer, Nepean Hospital. 

 

 

 

 

Wednesday, 27 August 2014 2:46:59 PM