Barwon Health Research - Post Approval Project Management

Post Approval Project Management

Researchers are responsible for continuous monitoring and reporting, throughout the life of a research project, to ensure it continues to adhere to the National Statement (2018), the Australian Code for the Responsible conduct of Research (2018) and Institutional, State and National laws, guidelines and policies.

Ethics approval and governance authorisation of your research project only remain valid when the HREC, RGO and Sponsor are kept up to date on the conduct of your research project. The Principal Investigator is responsible for monitoring the project and reporting the following information to REGI.

Due Annually

Progress Reports

The Barwon Health Human Research Ethics Committee (BH HREC) is required to monitor all approved research in accordance with Chapter 5.5 of the National Statement on Ethical Conduct in Human Research (2007, updated 2018). Ongoing ethical approval is conditional on receipt of Progress Reports annually. Failure to submit an Annual Progress Report may lead to suspension of ethical approval or governance authorisation.

When are reports due?

Progress reports are due on the anniversary of approval each year. Occasionally, reports may be requested at more frequent intervals (e.g. auditing).

How do I submit a Progress Report?

Barwon Health requires progress reports to be submitted via Ethics Review Manager (ERM). You can find the progress report listed as a sub-form off the HREA or SSA. Please ensure the Barwon Health reference number is included on the form and the Principal Investigator has signed the form before submitting.

Please complete a Project Progress Report from the HREA:

For all single-site research projects; and
Where BH HREC are the reviewing HREC for a multi-site project

Please complete a Site Progress Report from the SSA:

For all multi-site research projects where Barwon Health is not the reviewing HREC.

If you are experiencing difficulty with ERM, please see the Victorian Clinical Trials and Research ERM training tools page.

What should the report include?

Progress reports should give the HREC or Governance Officer an overview of what has occurred in the research project at the Barwon Health site thus far, such as:

Total participants recruited so far (site and total) with explanation if recruitment is not to target, or there have been withdrawals
Whether the project is meeting expected milestones
Any safety incidents that have occurred (include copies of safety reports and complete annual safety report)
Details of any auditing procedures
Whether the project is meeting budgetary requirements

Multi-site progress reports should include:

Reviewing HREC acknowledgement of Site Progress Report (or acknowledgement of the overarching HREC Progress Report covering all sites, where acknowledgement of the Site Progress Report is not available)
Annual safety report
Current insurance certificate

Process of review and acknowledgement

All progress and final reports will be reviewed and acknowledged within ERM. Once acknowledged, you will receive an automated email message notifying you of the acknowledgement. If further information or revision is required, a request for information will be sent via ERM outlining what is needed before acknowledgement can be provided. Incomplete documents with inconsistent or absent information and signatures will be returned to researchers for resubmission, and will not be approved.

Annual Safety Report

Due on Project Completion

Final Reports

Final reports should be submitted once the project has been completed.

The definition of completion is different for each type of study:

For commercially sponsored clinical trials - a study is considered complete once the closeout visit has been completed.
For investigator initiated clinical trials - a study is considered complete once the last patient has completed follow-up and the data have been analysed.
For other research projects - a study is considered complete once data collection is complete and there is no further contact with patients or access to medical records or other sources of personal health or information and the data have been analysed.

How do I submit a Final Report?

Barwon Health requires final reports to be submitted via Ethics Review Manager (ERM). You can find the final report listed as a sub-form off the HREA or SSA. Please ensure the Barwon Health reference number is included on the form and the Principal Investigator has signed the form before submitting.

Please complete a Project Final Report from the HREA:

For all single-site research projects; and
Where BH HREC are the reviewing HREC for a multi-site project

Please complete the following steps for all multi-site research projects where Barwon Health is not the reviewing HREC:

Complete a Project Final Report (or Site Closure Report if Barwon Health is the only site closing) from the lead site’s HREA and save a pdf of the report; and
Complete a Site Notification Form from the SSA, attaching a pdf of the Final Report or Site Closure Report and central HREC approval of the Final Report

If you are experiencing difficulty with ERM, please see the Victorian Clinical Trials and Research ERM training tools page.

What should the report include?

Final reports should provide a wrap-up of the research and include:

Total participant recruitment (site and total)
Whether the project was completed on time
Any safety incidents that have occurred (include safety reports)
Whether any publications have resulted from the research
Explanations/learnings on what didn’t go to plan

Process of review and acknowledgement

Final reports will be reviewed and acknowledged within ERM. Once acknowledged, you will receive an automated email message notifying you of the acknowledgement. If further information or revision is required, a request for information will be sent via ERM outlining what is needed before acknowledgement can be provided. Incomplete documents with inconsistent or absent information and signatures will be returned to researchers for resubmission, and will not be approved.

Due as Required

Project Amendments

Once a research project has been ethically approved by a Human Research Ethics Committee (HREC), any change to its design or conduct throughout the life of the project, must also be ethically approved by the reviewing HREC.

An amendment must not be implemented at a site until the HREC or ethics review body has granted approval of the amendment and (if applicable) the site Research Governance Office has granted authorisation of the site governance amendment.

Depending on the nature of the amendment either an ethics amendment and/or governance amendment may be required.

An amendment can include changes to the:

Research Personnel (If Principal Investigator; ethics and specific site governance, If Associate Investigator; site specific governance only)
Sponsor (ethics and all site governance)
Protocol (ethics and all site governance)
PICF and other participant facing material (ethics and all site governance)
Investigator Brochure (ethics and all site governance)
Participating sites (ethics and specific site governance)
Agreements (specific site governance)
Any other changes that impact the ethics and governance of the study

You should submit all amendments and other post approval requirements on Ethics Review Manager (ERM) (link to login).

Please contact the Barwon Health RDU at [email protected] for further guidance.

Ethics amendments

Process:

Generate an Ethics amendment subform from the HREA in ERM. Complete the form. If submitting to BH HREC, please use the same BH Project number as your original project
Attach
- revised documents – clean and tracked copies with updated versions and dates where necessary.
- New documents
Ensure CPI/PI has signed the form electronically with ERM

Submit the Ethics amendment form in ERM. This will be reviewed at the next HREC meeting by the same HREC committee as the original HREA submission. You will be informed of the outcome via ERM. An amendment can only been implemented at a site after the HREC has granted approval of the amendment and (if applicable) the site RGO has granted authorisation of the site governance amendment.

If you are unsure if you need to submit an ethics amendment, please contact the Barwon Health RDU on [email protected] for guidance.

Governance amendments

Process:

Generate an amendment subform from the SSA in ERM. Complete the form. Please use the same BH Project number as your original project
Attach
- HREC approval letter for ethics amendment, if required
- Revised approved Master documents
- Revised site specific documents with clean and tracked copies with updated versions and dates where necessary.
- New Site specific documentation
- Updated agreements
- BH Recipient created tax invoice for Governance fees
Ensure Site PI has signed the form electronically within ERM

Submit the SSA amendment form in ERM. This will be reviewed by the Barwon Health RGO team. Any changes to the research agreement will need to be reviewed by the Research Management Committee. You will be informed of the outcome via ERM.

If you are unsure if you need to submit an SSA amendment, please contact the Barwon Health RDU on [email protected] for guidance.

Safety Monitoring and Reporting