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:
Post approval reporting e.g. annual reports
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.