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On-site monitoring

The Centres for Health Research administers a comprehensive monitoring program that aims to:

  • ensure patient and staff safety
  • ensure the use of high quality data
  • promote research best practice

All research projects conducted in Metro South Health facility campuses are eligible for a routine on-site monitoring visit. Research projects are randomly chosen for monitoring however particular research projects may be ‘targeted’ if there is cause.

The on-site monitoring visit will involve a meeting with the Principal Investigator (PI) and research project personnel to discuss matters relating to the research and its conduct. This may include:

  • the procedure for obtaining informed consent
  • safety reporting
  • data storage and protection
  • the participant recruitment process

The Metro South Health Research Monitoring Office will contact the Principal Investigator (PI) via telephone and in writing at least two weeks in advance of a monitoring visit. A checklist will be provided ahead of the on-site monitoring visit. Further findings may require follow up.

Please see the Research Governance (Monitoring) Procedure (PR2017/117) (PDF, 220.94 KB) for more information regarding the monitoring process.

Sponsors

Sponsors must submit their reports for their monitoring visits to the Metro South Health Research Monitoring Office.

Site master file maintenance

Metro South Health recommends that a site master file is established during the Initiating and planning a research project stage and maintained throughout the life of the research project. The site master file should contain all essential documents pertaining to the research project and be accessible for review by the sponsor’s representatives (e.g. Metro South Health Research Monitoring Office).

Read more about clinical trial site master file maintenance.

Last updated 18 May 2018
Last reviewed 17 May 2018

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