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Amendments

Amendments to your research project which may affect the ongoing ethical acceptability of the study or the suitability of the research site must be submitted for review.

How do I submit an amendment?

To submit an amendment, please submit the Amendment Application Form (XLS, 762 KB) following to the Centres for Health Research including:

  • a brief description of the changes
  • the rationale for the changes
  • any implications for the ongoing conduct of the study
  • Head of Department and Business Finance Manager approval to support the ongoing conduct of the study within the department. This can be provided by email or via  letter of support.

Submit the amendment to:

There is no specific deadline for amendments.

Who receives the amendment?

  • Project amendments that may affect the ongoing ethical acceptability of the research are submitted to the Human Research Ethics Committee (HREC) for review.
  • Project amendments that only affect the site acceptability of the research are submitted to the Centres for Health Research governance office.
  • Project amendments that may affect both the ongoing ethical acceptability AND the site acceptability of the research are submitted to the Human Research Ethics Committee (HREC) for review and, once HREC approval has been granted, are submitted to the Centres for Health Research Governance Office for final authorisation.
  • Project amendments that do not affect the ongoing ethical acceptability OR the site acceptability of the research (e.g. typographical errors) should be submitted in hard copy to the Human Research Ethics Committee.
  • For studies that are externally HREC approved, please submit the HREC approval of the amendment along with any updated site specific changes to the Research Governance Office.

Fees

Other than administrative changes all amendments to previously approved pharmaceutically sponsored research protocols that are submitted to the Metro South Health HREC for review are subject to a levy of $650 (inclusive of GST).

An administrative amendment is defined as changes to the details of research that have no significant implications for participants or for the conduct, management or scientific value of the study for example

  • correction of typographical errors in the protocol or other study documentation
  • amended contact details for the sponsor or project staff
  • appointment of new or change of support staff contact.

There is no charge for amendment submitted to the Research Governance Office.

Last updated 2 September 2016
Last reviewed 3 March 2015

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