What to report
You must report any changes or updates to your research study through Ethics Review Manager (ERM).
These include:
- changes to investigators
- changes to the protocol, participant information and consent form, or other study documents used at the site
- changes to agreements, indemnity or insurances
- safety reports
- progress reports
- final report and study findings.
How to report
You’ll need to create a Post Authorisation Notification sub-form in ERM to upload your reports.
Amendments
Include or upload any changes to your research, such as:
- reason and details of the amendment from the lead investigator
- all new and updated documents – include tracked and clean copies of each document with an updated version number and date
- an amendment approval letter from the Human Research Ethics Committee.
Safety reports
Upload any safety issues within these timeframes:
- significant safety issues and urgent safety measures taken, within 72 hours of the event.
- action taken by the sponsor, within 15 days.
- any protocol violations or deviations which involve Torres and Cape HHS participants or data integrity, within 15 days.
- temporary stops or early termination of study, within 15 days.
To learn more, read the guidance on safety monitoring and reporting on the NHMRC website.
Progress reports
You must report on the progress of your project each year. Upload the following in ERM:
Final reports
For your final report you must upload the following in the ERM.