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Amendments

Amendments to a research project which may affect the ongoing ethical and scientific acceptability of the research project or the suitability of the research site must be submitted for review to both the Metro South Health Human Research Ethics Committee (HREC) Office and Metro South Health Research Governance Office.

Amendments for the Metro South Health Human Research Ethics Committee (HREC) Office must be submitted through the ECF6 Amendment Form including:

  • a brief description of the changes
  • the rationale for the changes
  • any implications for the ongoing conduct of the research project

Amendments for research governance authorisation require completion of Part B of the RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form).

  • Research governance requires - Head of Department and Business/Finance Manager approval to support the ongoing conduct of the research project within the Division/Department.

Some requirements for amendments are as follows:

  • Research project amendments that may affect the ongoing ethical acceptability and site acceptability of the research are submitted to the Metro South Health Human Research Ethics Committee (HREC) for review.
  • Research project amendments that only affect the site acceptability of the research are submitted to the Metro South Health Research Governance Office.
  • For research projects that are externally Human Research Ethics Committee (HREC) approved, please submit the Human Research Ethics Committee (HREC) approval of the amendment along with any updated site specific changes on the RGF1 Research Contracts Approval and Study Execution Form (Application and Submission Form) to the Metro South Health Research Governance Office.

Please see the Ethical and Scientific Review of Human Research Procedure (PR2017/133) (PDF, 413.65 KB) and the Research Governance (Site Specific Assessment) Procedure (PR2017/116) (PDF, 370.43 KB) for more information regarding requirements for amendments.

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 research project for example:

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

Amendment fees

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

Other than administrative changes all amendments to previously approved pharmaceutically sponsored research protocols that are submitted to the Metro South Health Human Research Ethics Committee (HREC) for review. Please see Research Fees Procedure (PR2017/123) (PDF, 203.26 KB) for more information.

PowerTrials

It is mandatory to maintain the PowerTrials record in the Electronic Medical Record.

Please see PowerTrials - Electronic Medical Record Research Support Module Procedure (PR2017/118) (PDF, 233.39 KB) for more information, or the Metro South Health Digital Quick Reference Guides for managing amendments and enrolment of patients.

Last updated 18 May 2018
Last reviewed 17 May 2018

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