Managing your project
After ethics approval and governance authorisation, researchers are required to report their progress and advise of any project changes. All amendments and reports are submitted via ERM.
Amendments
Amendments to approved projects must be submitted via ERM using the Mater Amendment Form and should include:
- summary of the amendment
- new documents
- amended documents (one tracked and one clean copy of each with a new version number and date in the footer)
- HREC approval letter (external HRECs only)
Progress Reporting
An annual progress report must be submitted via ERM using the Mater Progress and Final Report Form as a condition of ongoing HREC approval and/or Governance authorisation.
| Reviewing HREC | Mater annual report deadline | Submission requirements |
|---|---|---|
Mater Misericordiae Limited HREC | Anniversary of HREC approval | Any supporting documents |
External HREC | As per HREC reporting deadline, annually |
|
Safety Reporting
Unless otherwise stated in your approval/authorisation letter, for externally-sponsored clinical trials, Mater follows the NHMRC guidance for Safety monitoring and reporting in clinical trials involving therapeutic goods.
Projects that involve the use of an investigational product - an annual safety report must be submitted via ERM using the Mater Annual Safety Report Form as a condition of ongoing HREC approval and/or Governance authorisation.
| ERM Form | Purpose | Submission Requirements |
|---|---|---|
Mater Deviations and Breaches | To notify Mater HREC/RGO of deviations, suspected breaches and serious breaches to the protocol or Good Clinical Practice. |
|
Mater Annual Safety Report form | To notify Mater HREC/RGO of any changes to safety information for projects that involve the use of an investigational product. |
|
Mater DSMB Recommendations | To notify Mater HREC/RGO of Data Safety Monitoring Board (DSMB) letters of recommendation. Note: DSMB recommendations to “continue as planned” are not required (external HRECs only) |
|
Mater SAE/SUSAR/USADE | To notify Mater RGO of an individual:
|
|
Mater Significant Safety Issue | To notify Mater HREC/RGO of any significant safety issues, including urgent safety measures, temporary halts or early terminations of the trial. |
|
Final Report
A final report must be submitted via ERM using the Mater Progress and Final Report Form on completion of your project or if the project is abandoned so that the project and/or Mater site can be closed.
Onsite monitoring
Mater RGO can monitor any research project conducted at Mater. The level of monitoring is determined based on the level of risk and other factors. This ensures research projects are conducted in accordance with Good Clinical Practice, ethics approval and institutional requirements.