Post approval for research at SALHN
The SALHN Research Hub has a responsibility to monitor all research authorised to be conducted at a Southern Adelaide Local Health Network (SALHN) site. SALHN has produced monitoring and reporting guidelines to assist researchers in understanding their obligations.
Once you have received ethics and governance authorisation for your research project, there are mandatory reporting requirements you must adhere to Failure to do is a breach of a breach of the NHRMC Australian Code for the Responsible Conduct of Research R17, R22, the National Statement chapter 5.5 and the terms and conditions of the ethical approval for this study.
Failure to submit the required report may result in the ethics approval being withdrawn and the application closed.
The SAC HREC has an obligation, under Chapter 5.5 of the National Statement, to monitoring the research it approves. Research approved by the SAC HREC is primarily monitored by annual submission of progress reports. All principal investigators (or delegate) are required to submit a progress report or a final report by the anniversary of the original SAC HREC approval.
Failure to submit a progress report or final report by the due date violates the terms and conditions of SAC HREC approval and will result in immediate suspension of the SAC HREC approval until a valid progress report or final report is submitted. Submission of a valid progress report will continue the SAC HREC approval for the next 12 months, at which point a new progress report will be due.
A final report is due upon completion of the project. Completion of the project is defined as the time point where all participants have completed any study related activity and all access to medical records has ceased.
- Progress Report Form (DOCX 76KB)
- Contract Amendment Form (DOC 315KB)
- Final Report Form (DOCX 75KB)
- Project Amendment Form (DOCX 127KB)
- National Mutual Acceptance monitoring and reporting table (EXCEL 436KB)
- Protocol/GCP Suspected or Serious Breach Report (DOCX 67KB)
- Safety Monitoring Report (DOCX 235KB)