A tracked changes version of amended documentation e.g. changed protocol or Information Sheet
A clean version of amended documentation CV if the Principal Investigator is being changed
Site support if adding a new site.
Site support if the amendment may affect a site’s participation.
Any other documentation that supports the amendment request.
Please note: Participating sites should be notified of amendments that have the potential to affect their willingness or ability to participate.
Notifications of events not requiring an amendment may be in the form of a letter or a template created specifically for a clinical trial.
Notifications of Adverse reactions and events relating to clinical trials should be made in accordance with current NHMRC reporting requirements described in the document Safety monitoring and reporting in clinical trials involving therapeutic goods.
3. Annual Reports
A condition for ethics approval by the Human Research Ethics Committee of the NT Dept of Health and Menzies School of Health Research is regular reporting by investigators. This is in accordance with guidelines regarding monitoring of research from the National Statement on Ethical Conduct in Human Research.
The HREC requires an annual progress report. The date that the report will be due is included on all approval letters. The report consists of a completed template and a summary of activities from the previous 12 months.
4. Final Reports
A Final Report is due upon completion of all foreseeable aspects of an investigation. This should be following completion of participant involvement, data analysis, principal manuscript preparation, and stakeholder feedback.
The final report consists of a completed template and a summary of all major activities, results and outputs.