Harmonising Post Approval Forms
Progress Report - National Consultation 2
About the project
With updates to the National Statement and efforts to harmonise processes across jurisdictions (particularly for multicentre research projects), we are seeking feedback on the next version of the harmonised progress report form, with the aim of reducing duplicate reporting requirements, ensuring compliance and making it easier to enter and/or review the required information.
The progress report is an essential document that must be submitted annually by the Coordinating Principal Investigator and (CPI) Principal Investigator (PI) to ensure compliance with ethical standards in research.
The latest version incorporates feedback from National Consultation 1 (September 2025) and targeted consultation with stakeholders across Australia. Feedback from this consultation will inform final refinement and pilot activities.
Consultation closes Friday 18 September 2026
What we need from you
✅ Review the draft Progress Report form (review guidance on page 1)
✅ Attend an optional webinar if you'd like a guided walkthrough
✅ Complete the feedback survey relevant to your role
✅ Submit feedback by Friday 18 September
✅ Share this message with your colleagues to increase feedback
What has changed with this version?
- Technical language reduced usability for some stakeholder groups.
- Additional consideration was required for a broader range of study types.
- The purpose of some information requests was not always well understood.
- Branching logic required simplification to reduce submission errors.
- Stakeholders supported process simplification but requested clarification on the integration of Ethics and Site-Specific reporting.
Consultation 2 We Changed
- Stronger focus on plain English.
- Targeted feedback sought from specific stakeholder groups, including Decentralised Clinical Trials, Registries, Data Linkage studies and Sponsors.
- Guidance and warnings included added to support understanding and improve submission quality.
- Branching simplified.
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Questions redesigned so Ethics reporting questions can function independently, while Site-Specific questions complement Ethics reporting requirements.
Review the draft progress report form
Attend a walkthrough webinar (Optional)
Q&A from webinar 1 and 2 is now available at the bottom of this page.
Join a member of the working group for a guided walkthrough of the draft Progress Report form.
These sessions provide an opportunity to:
- Understand the intent behind proposed changes
- Ask questions
- Clarify requirements
- Inform your feedback submission
Click to register:
Friday 14 August 1-2pm Tuesday 18 August 12-1pm Wednesday 19 August 9.30-10.30am
- The focus of this consultation is the content and structure of the questions.
- System functionality, workflows, automation and data pre-population are outside the scope of this consultation.
- Ethics reporting questions are designed to operate independently.
- Site-Specific reporting questions are designed to complement Ethics reporting and would be completed once per site.
- The form is intended to support implementation without the need for local supplementary reporting forms.
Provide your feedback
Select the role that best describes you. If you fit multiple roles, you can complete multiple feedback forms or select the role that you primarily identify.
We are particularly interested in feedback on:
- Ease of completing the form
- Clarity of questions and guidance
- Suitability for different study types
- Ethics and Site-Specific reporting requirements
- Potential implementation challenges
Click to complete feedback:
Researchers & Research Teams Research Offices (Ethics & RGO) HREC Members
Forms close Friday 18 September.
The project team
This project was initiated by members of the National Mutual Acceptance scheme (NMA) to explore opportunities to harmonise post approval forms for NMA participating organisations. The group was represented by all states and territories across Australia with a broad range of experience in human research.
In March 2026 the scope of the project was reduced with members from NSW, ACT, TAS and SA continuing the project. The aim of the project remained the same and feedback from all is welcome regardless of which jurisdiction you conduct or review research.
Need More Information?
For further information, contact the Post Approval Forms Working Group
Webinar Q&A
Q1. The Introduction section states: "Incorrect pre-filled data in this section indicates a data quality issue and should be corrected prior to submitting." How will researchers correct incorrect data? Will instructions be provided?
Answer:
Yes. The intention is that researchers will be provided with clear guidance on how to correct any incorrect pre-filled information before submitting the form.
As the Harmonised Progress Report Form may be implemented across multiple research management systems, detailed instructions have not yet been included in the form itself. Guidance will be developed as part of implementation to ensure researchers understand how to address data quality issues.
Q2. In the Final Report section, the question asks: "How is study data or findings being shared with participants?" Is the researcher only required to select a method, or provide further details? If findings are shared after the final report is submitted, does this need to be reported to the HREC?
Answer:
Researchers are only required to indicate how findings are being shared by selecting from the available options in the form. An "Other" option is available if an alternative method needs to be described. No additional information is required beyond this response.
Once a study's final report has been submitted and the study is considered closed by the HREC or institution, there is generally no requirement to submit further updates regarding dissemination activities.
The National Statement (Section 5.4.12) recognises that institutions may define study closure differently. Examples include:
- Completion of study interventions
- Completion of data analysis
- Submission of a final report
- Completion of participant follow-up
- Publication of study findings
The key consideration is whether participant safety, data integrity, or resource management remain active concerns.
Q3. If a study publishes journal articles after the final report has been submitted, where should these publications be reported?
Answer:
Journal publications arising from approved research generally do not require separate ethics review or approval, provided they are consistent with the original ethics approval, participant consent, and privacy requirements.
If the final report has already been submitted and the study is considered closed, subsequent journal publications would not typically be submitted to the HREC.
Q4. For clinical trials, sponsors often request documents such as Clinical Study Reports (CSRs) after the final report has been submitted. Should guidance be included stating that no further submissions can be made once the final report is submitted?
Answer:
There may be differences between when a sponsor considers a study complete and when an HREC or institution considers a study closed.
As outlined in the National Statement (Section 5.4.12), institutions determine their own closure requirements.
Further guidance on managing post-closure sponsor documentation may need to be considered during implementation.
Q5. How should Clinical Study Reports (CSRs) be handled if sponsors require them to be submitted or acknowledged after a study has been closed?
Answer:
The management of CSRs after closure has not been specifically addressed within the current scope of the project.
This has been identified as an area requiring further consideration during future development and implementation discussions.
Q6. Will all fields in the Harmonised Progress Report Form be mandatory?
Answer:
The current intention is that almost all questions will be mandatory to ensure complete and consistent reporting.
There may be a small number of exceptions, but the overall approach is that researchers should complete all applicable questions before submission.
Q7. The safety reporting question asks whether any safety events or incidents have occurred. Could a free-text explanation be required to improve reporting quality and awareness?
Answer:
Previous consultation feedback has emphasised minimising free-text responses unless they are absolutely necessary.
The project team has attempted to balance:
- Collecting sufficient information for monitoring purposes; and
- Reducing administrative burden for researchers.
If stakeholders strongly support requiring additional details for safety-related responses, this feedback will be considered and may lead to future changes to the form.
Q8. Will individual questions and responses be reportable, or will the completed form simply be uploaded as a document?
Answer:
This will depend on the functionality of the system in which the form is implemented. Reporting capabilities may vary between different research management systems.
Q9. For internally reviewed HREC projects, is the expectation that Ethics and Governance progress reports will be submitted together by the Coordinating Principal Investigator (CPI)?
Answer:
The project team has not yet determined a preferred workflow for this scenario.
Future work will focus on understanding researcher and research office requirements, available system functionality, and how data can be efficiently shared between ethics and governance processes.
Q10. Will there be functionality to alert researchers when their ethics approval has expired?
Answer:
System functionality such as alerts, notifications, or automated reminders has not been considered as part of this consultation.
The project is focused on developing a harmonised form that can be used across multiple systems. System-specific functionality will be determined separately by individual platforms.
Q11. Site status information is often inaccurate. Will researchers be able to update incorrect site statuses before submitting a report?
Answer:
This has not yet been finalised.
Options being considered include:
- System-generated site statuses;
- Researcher-maintained site statuses; or
- A combination of both approaches.
There is also an ongoing role for Research Office staff in reviewing and validating submitted information.
Q12. If organisations identify issues after implementing the form, what is the process for updates, refinements, or customisation?
Answer:
The Harmonised Progress Report Form is being introduced as a pilot, recognising that practical use may identify opportunities for improvement or reveal unintended consequences.
Feedback gathered during the pilot phase will help refine the form before it is finalised.
The goal is to achieve a high level of harmonisation while recognising that individual systems may differ in their capabilities and levels of customisation. Future changes will aim to balance consistency across organisations with practical implementation needs.
