Reporting for research projects

After you start your research project you’ll need to report on your progress.

This includes submitting annual progress reports and a final report when you finish your research.

You’ll also need to report any changes to your research project.

These include changes to:

  • your research plan (protocol)
  • your ethics or site specific assessment (SSA) approvals
  • the people or organisations involved in your research, including sponsors
  • participant information and consent forms (PICF)
  • contracts and agreements
  • insurance and funding.

How to report

You can submit your reports and research project changes using the Ethics Review Manager (ERM).

For more information and instructions on reporting read our Post approval: research amendments, reporting and closure [PDF 234.17 KB].

Annual reports and final report

You must submit your annual progress report by 30 April each year.

You must submit your final report by 30 April in the year after:

  • your funding end date
  • your research is complete
  • your research is discontinued.

The following guides explain how to prepare your reports.

Changes to your research project

Make sure you use track changes if you're making changes to your documents so we can see what you've added, changed or deleted.

For more information read our Track change guide [PDF 485.03 KB].

PowerTrials

PowerTrials is part of Queensland Health’s integrated electronic medical record (ieMR) system.

If you’re conducting a clinical trial in any of our hospitals or health service you must use PowerTrials to build a record of your study.

Please email MSH-Research@health.qld.gov.au if you need any help with PowerTrials.

Request a PowerTrials data extract

You can request a PowerTrials data extract through the Metro South Health Data Hub.

If you are an external researcher, a Metro South Health collaborator on your project can request a PowerTrials data extract for you.

PowerTrials guides

About our research monitoring program

We monitor research projects conducted in our hospital and health service. We may use external contractors for research monitoring.

We monitor research projects to make sure that:

  • patients and staff are safe
  • data is accurate
  • projects comply with the protocol, Good Clinical Practice and other laws and standards.

Your monitoring plan

If Metro South Health is your sponsor we'll provide monitoring plan templates to the principal investigator.

The monitoring plan describes what will happen during monitoring visits and the monitoring activities that take place during monitoring visits.

The sponsor and principal investigator will review and update the monitoring plan during your research project.

If Metro South Health is your sponsor, we'll follow the guidelines in our Metro South Health sponsorship of CTN scheme trials [PDF 244.13 KB].

What projects are monitored?

Any research projects conducted within Metro South Health may be monitored. We choose projects randomly, but we may focus more on some projects if there are issues to fix.

What happens during a monitoring visit

Visits can happen on site or remotely. During a visit we'll meet with the main researcher and project team to talk about the research progress.

We'll then go through the activities that are in the monitoring plan. These could include:

  • looking at participant reports
  • checking safety reports
  • checking files at the study site
  • looking at consent papers.

The time it takes for a monitoring visit can vary. It may take an hour or a full day.

Preparing for a monitoring visit

We'll contact the principal investigator by phone or email at least 2 weeks before our visit and give them documents to help prepare for our monitoring visit.

Using ieMR for monitoring

For more information about accessing the ieMR for study monitoring purposes, email:

More information about monitoring and compliance

Contact us

For more information about post authorisation processes for your research project email MSH-Research@health.qld.gov.au.

Last updated: September 2024