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Maintaining and managing a research project

Key messages

  • It is vital that research projects in Metro South Health are monitored and maintained throughout the entire life of the research project. There are several components to consider as part of the maintaining and managing a research project process:
    • On-site monitoring
    • Post approval reporting e.g. annual reports
    • Amendments
    • Safety reporting
    • Suspension or early research project closure
  • The on-site monitoring process provides education, support and health/assistance, which may assist novice researchers.
  • The most common errors found as a result of the on-site monitoring process centre around:
    • Participant Information and Consent Forms (PICFs) signatures and dates (the Participant Information and Consent Forms (PICF) must be signed before the person commences participation)
    • Version control of all research project documents – the Metro South Health Human Research Ethics Committee (HREC) ethical clearance letter must reference the same version of the document which is being used by the research project.
    • Contracts – must be active and be approved by all relevant delegates
    • Funding arrangements (particularly if external) – must be kept up to date and managed.
  • The Metro South Health Research Monitoring Office has limited scope to check source data verification – this must be checked by the research team.
  • Annual progress reports are a requirement therefore it is recommended that researchers set a reminder in their calendar one month a head of the research project’s one year anniversary.
  • Complaints and matters pertaining to research misconduct are treated seriously by Metro South Health as part of research integrity.

In this section

On-site monitoring

Information about on-site monitoring, post approval and annual reporting, amendments and research integrity.

Post approval reporting e.g. annual reports

Clinicians and researchers are required to submit a number of annual progress reports to a number of bodies.

Amendments

How to submit amendments to a research project which may affect the ongoing ethical and scientific acceptability of the project or the suitability of the research site.

Safety reporting

Requirements for reporting safety and adverse events.

Suspension or early research project closure

From time to time a research project may be suspended with approval from the Metro South Health Human Research Ethics Committee (HREC).

Complaints and research misconduct

Information on how to make a complaint about researchers or the conduct of research, or about the conduct of the Metro South Health Human Research Ethics Committee (HREC).

Last updated 18 May 2018
Last reviewed 17 May 2018