Research Development Unit (RDU)

Progress Reports - due 1 August each year

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 (2023). 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.

Commencing in 2024, progress reports for all research projects are now due 1 August each year

This applies to all studies reviewed by the Barwon Health HREC and those reviewed by external HRECs with Barwon Health governance authorisation. 

Progress reports for all projects are now due on 1 August each year, as opposed to the anniversary of project approval. Reports should encompass the time period from the last progress report submitted.

In addition, the annual progress report template has changed to a REDCap survey that is easier for Investigators to complete and collects data that is more relevant to Barwon Health’s requirements. Investigators no longer need to submit a progress report via ERM.

Please note: Do not wait for the August deadline to submit a final report at the completion of your project. Investigators should submit a final report following study completion via ERM as usual.

The progress report template link will become active on this page on 1 July 2024, giving Investigators one month to submit a progress report for each project.

Follow these steps to complete an annual progress report

1. Follow this link to begin your progress report: https://redcap.link/BHAnnProg
2. Enter details of your project, including reference numbers, Principal Investigator details, project title, project type and HREC approval details
3. Provide a brief lay summary of the project and a brief update of progress
4. Provide updates about changes to protocols, PICFs, Investigators
5. Provide updates about recruitment, challenges faced
6. Complete the declaration
7. Click submit

Questions? Find the answers here or contact the Barwon Health Research Development Unit at [email protected] or (03) 4215 3374.

 

Annual Safety Reports

An Annual Safety Report (ASR) should be submitted for all clinical trials on an annual basis (preferably at the same time as the Annual Site Progress Report).

The purpose of the ASR is to provide a clear summary of the evolving safety profile of the trial and allows the HREC/RGO to assess whether ongoing safety monitoring is being conducted appropriately and if the trial’s safety monitoring plans are being followed.

The ASR should generally include:

• A brief description and analysis of new and relevant findings
• For Investigational Medicinal Products (IMPs) not on the Australian Register of Therapeutic Goods, a brief analysis of the safety profile of the IMP and its implications for participants taking into account all available safety data and the results of relevant clinical or non-clinical studies
• A brief discussion of the implications of the safety data to the trial’s risk-benefit ratio
• A description of any measures taken or proposed to minimise risks

The Executive Summary of safety information produced for international regulators, such as a Development Safety Update Report (DSUR), may be submitted in place of the ASR.

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 Site Final Report from the SSA (this can be done by selecting the Site Progress Report sub-form, and then choosing ‘Site Final Report’ option when prompted), and attach a copy of the central HREC’s Project Final Report/Site Closure Report along with central HREC approval, if available

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.

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 only)
• 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.

Submission Process for Ethics Amendments

1. Complete an Ethics Amendment Request sub-form from the HREA in ERM (if submitting to BH HREC, please use the same BH reference number as your original project).

2. Attach new documents and/or revised documents (including clean and tracked copies with updated versions and dates where necessary).

3. Ensure the CPI/PI has signed the form electronically within ERM prior to clicking the Submit button.

4. The amendment will be reviewed at the next HREC meeting by the same HREC that provided the initial ethics approval, and  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.

Submission Process for Governance Amendments

1. Complete a Governance Amendment Request sub-form from the SSA in ERM (please use the same BH reference number as your original project).

2. Attach the following documents to your submission (if applicable):

• HREC approval letter for ethics amendment, if required
• New or revised master documents
• New or revised site specific documents (including clean and tracked copies with updated versions and dates where necessary)
•  
• Updated agreements
• BH Invoice Request Form for governance fees

3. Ensure the site PI has signed the form electronically within ERM prior to clicking the Submit button.

4. The amendment 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 (the RDU will facilitate review and sign off on your behalf).  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

Please click here to view the Barwon Health Research Safety Monitoring, Reporting and Management Procedure (updated July 2023).

A safety report is required for the following;

• Any event that may impact the safety, dignity, or welfare of participants and/or the integrity of project data
• Protocol breaches (suspected, non-serious and serious)

A Riskman may also be required – please see the ‘How to Enter a Clinical Trial Incident on Riskman’ guide for assistance with entering a Riskman related to a Clinical Trial. It may also be useful for entering non-trial research incidents.

To prepare and submit a safety report, select the appropriate report from the Sub-Form drop down menu in Ethics Review Manager (ERM). 

 

Notifications

Any additional information that requires reporting to HREC or RGO e.g. Sponsor letters, central HREC letters, notification of any unforeseen events or matters which may impact the conduct of the project at this site, etc.

 

Complaints

Participant complaints should be reported directly to the RGO/RDU via ERM as a sub-form from the SSA.

Research integrity complaints can be reported directly to the RDU Manager by emailing [email protected].

Audits

The Barwon Health RDU may conduct an audit of your research project at any time to ensure it is compliant with the conditions of ethics and governance approval.

An auditor may request a report on any aspect of your project. You will receive a minimum of two weeks’ notice of a pending audit.

For more information, visit the Audits page.

 

Key Performance Indicators

From time to time, you may be contacted to provide project KPIs for organisational reporting purposes. Requests will come via email, and will generally relate to:

• Recruitment to date
• Staff to participant ratio
• Participant feedback
• Income generated