Why is it important to maintain and monitor research projects?
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 (eg annual reports)
- Safety reporting
- Suspension or early research project closure
The monitoring process provides education, support and health/assistance, which may assist novice researchers.
The most common errors found as a result of the monitoring process centre around:
- Participant Information and Consent Forms (PICFs) signatures and dates (the 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 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.
Who is eligible for a routine on-site monitoring visit?
- 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.
What does an on-site monitoring visit involve?
The on-site monitoring visit will involve a meeting with the principal investigator 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.
How much time will I be given before the on-site monitoring visit?
- The Metro South Research will contact the principal investigator 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.
What does site master file maintenance entail?
- Metro South Research 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.
How does this affect Sponsors?