Category: <span>Education and Resources</span>

When a potential new medicine is tested on humans for the first time it is a milestone. It is thoroughly tested for safety before reaching this stage.

Often, it’s tested on animals, but increasingly New Approach Methodologies (NAMs) are being used (previously known as Non-Animal Models). NAMs are non-animal or reduced-animal scientific methods used to evaluate the safety and efficacy of drugs. These alternative technologies can include in-vitro human models (such as organoids and organ-on-a-chip) and in-silico (computer-based) modelling.

Australia’s largest provider of Human Research Ethics Committee services, Bellberry, and ASCEPT (Australasian Society of Clinical and Experimental Pharmacologists & Toxicologists) have been working together to develop robust guidance for the use of NAMs.

Two workshops have been held with international and Australian experts over the last two years.

Following the last workshop, Alison Rogers spoke with three leaders in the field to find out more about this growing alternative technology to kick off the 2026 season of From Lab to Life.

The National Statement on Ethical Conduct in Human Research is the principal reference for research involving humans in Australia and is the guiding document for Human Research Ethics Committees. The National Statement is released by the National Health and Medical Research Council (NHMRC) and is periodically updated to stay relevant to evolving research practices, ethical understanding and community needs.

The 2025 revision, originally due to take effect on 1 October 2025, has been postponed until early 2026. However, institutions are encouraged to adopt it earlier and Bellberry will apply the changes from 1 October 2025.

The 2025 revision of the National Statement incorporates a fully revised Section 4 and consequential or minor changes to almost all other sections. The revised National Statement includes the following major thematic changes in Section 4:

• framing the need for additional consideration for individual participants or groups of participants in terms of increased risk of harm, rather than in terms of vulnerability
• emphasis on inclusion of individuals and groups frequently excluded or under-represented in research
• drawing a distinction between research with people who are at increased risk due to characteristics or circumstances, and increased risk due to research contexts
• removal of the need for research involving participants potentially at increased risk to automatically require review by a full HREC, enabling the use of alternative review processes for lower risk research with the same participants, where appropriate.

The revisions also include recognition of issues related to research with Aboriginal and Torres Strait Islander people and communities in the Preamble and Section 1 of the National Statement and a revised Chapter 4.7.

We encourage all researchers to become familiar with the updates. A summary of the changes can be found on the NHMRC website.

In the September issue of our Operations Update please find articles on:

• New Bellberry office address
• New eProtocol registrations contact email
• Bellberry user satisfaction survey
• End of year meeting and submission dates
• Digital scribes
• National Statement 2025 Update
• When the study is full – what about the next screened participant?

Without the patient or participant we would not have clinical trials. These are the people who, in some cases, are volunteering to have treatments that have never been tried on humans before.

In It’s All About the Participant we hear first-hand about what it’s like to be the participant and ask how could the experience be improved for others?

In Episode 9 of From Lab to Life we take a deep dive into the experience of those that have been on life-changing clinical trials.

Bellberry is pleased once again to offer our grant program to support participant engagement at scientific meetings. 

Conference organisers can apply to Bellberry for funding to create or enhance participant-centric programs to enable the participant voice to be represented and heard at their meetings. The ultimate aim of this grant funding program is to improve research by embracing participant perspectives. 

Applicants can apply for a grant up to a maximum of $20,000 – applications for 2024 close on 15 March 2024. 

Visit the link here for the Program guidelines and Application form

The Quality Update for December can be found here.

Content includes updates to some of our Bellberry Application (BA) and Monitoring of Approved Research (MAR) documentation, electronic HREC indemnity reminders, regulatory updates and more.

Please contact the Quality team at quality@bellberry.com.au if you have any queries regarding these updates.

Bellberry are proud to be a platinum sponsor of AAHMS (Australian Academy of Health and Medical Sciences) 2023. This year’s theme is Driving health equity – a pressing concern globally. This meeting is an opportunity to exchange ideas, consider the latest research findings, and discuss innovative solutions to improve the health outcomes of disadvantaged populations in Australia.

We look forward to seeing you there!

The ARMS 2023 conference is an in-person conference that will take place in Sydney from 6 – 8 September.

The conference theme is “Shifting Sands: Embracing the Diverse Future of Research Management” and it encourages us to harness uncertainty and change to cultivate a more resilient, inclusive, and sustainable future.

Trina O’Donnell, Director of Strategic projects at Bellberry will be attending and we look forward to seeing you there!

https://arms.eventsair.com/arms2023/

Discover the latest in Medical Technology at the 2023 AusMedtech Conference in Adelaide. With expert keynotes, panel discussions, and Q&A sessions, you’ll gain insights into the trends and breakthroughs that are propelling the industry forward.

Register now to discover a strong line up of speakers on topics that include Australian manufacturing success stories, navigating the distribution landscape, the evolving diagnostics landscape, the changing IP landscape and more.

REGISTER NOW! We look forward to seeing you there.

Clinical Trials – Quality or Quantity?

This year’s ARMS virtual conference theme is Research management. Research management is still a relatively new and evolving field however this evolution has been accelerated due to the global impact of COVID-19 on how we live, work and conduct research.

This year’s conference embraces this change and fosters discussions about what the future will look like and the changes in practice that are happening or need to happen to effectively support the research endeavour now and in the future. The theme includes four sub-themes that focus on the key aspects of an excellent and impactful research, science and innovation sector:

1. Research Priorities
2. Research Funding Challenges & Opportunities
3. Research Workforce
4. Research Infrastructure

CT:IQ (Clinical Trials: Thinking Smarter) Programme Director Lisa Eckstein will be joining the conference.

Please visit the ARMS event website to register.

Progress reporting realignment initiative

During 2021 Bellberry implemented a new approach to annual reporting, making use of technology solutions to improve performance. The primary objectives of the project were to:

• Support researchers maintain compliance with the terms and conditions of ethical approval and obligations under the National Statement on Ethical Conduct in Human Research. 
• Move all studies to a one-year term of approval, allowing system-generated alerts to be issued when progress reporting is due.
• Align progress reporting dates for all sites participating in the same research project. The DD-MMM cycle of the initial submitting site will determine the due date for all supplementary sites.
• Ensure Bellberry meet accreditation and certification obligations under AAHRPP (Association for the Accreditation of Human Research Protection Programs) and NHMRC (National Health and Medical Research Council).

Progress and final reporting: guidance materials 

Bellberry provides the following documents relating to progress and final reporting:

MAR G4 Progress and final reports

This guidance outlines researcher and sponsor obligations concerning progress and final reports as per clause 5.5.5 of the National Statement on Ethical Conduct in Human Research (2007 incorporating all updates).

MAR F4.1.1 Progress report (eProtocol questions) and MAR F4.1.2 Final report (eProtocol questions)

These forms provide a comprehensive list of questions asked via the eProtocol progress and final report form. These forms have been updated to include what researchers should consider when preparing responses to progress and final report questions. These forms also outline which responses are not acceptable and that the HREC will return reports with unacceptable responses. Researchers may use these forms to prepare responses before submission to eProtocol.

BA F2.1.12 Creating a progress report and BA F2.1.13 Creating a final report

These forms provide technical guidance to assist users unfamiliar with eProtocol to submit progress or final reports via the submission platform.

Progress and final reporting: Email correspondence 

Most email correspondence regarding progress and final reports will be sent to you from quality@bellberry.com.au. To ensure that these emails are received (and not moved to a junk/spam folder), please add quality@bellberry.com.au to your list of email contacts.

Progress reporting key information:

Please submit a progress report before an amendment if you are within the 30-day reporting period:

• If there are no issues with the progress report, it should not delay your ability to submit an amendment by more than 24 hours.

Auto alert expiry reminder emails:

• Be prepared to complete your progress report when you receive the first auto alert reminder email from eProtocol (emailed 30, 14 and 7 days before expiry).
• Bellberry administration will email sites that have not submitted a progress report/ethics approval extension request within the final days in an attempt to ensure they do not expire and run the risk of continuing to run their research without ethical approval.

The progress report/ethics approval extension may not be available for the following reasons:

• You have an amendment or final report ‘In Preparation’ or ‘Submitted.’ These submissions will need to be deleted before the progress report/ethics approval extension option will be available.
• You are more than 30 days in advance of the application’s expiry date.
• If none of the above reasons apply and you are still unable to see the progress report/ethics approval extension option, please email quality@bellberry.com.au with the Application ID/PI name in the subject line and a short message informing the team that you do not have an option to select a progress report/ethics approval extension.

Which pages can be updated:

• Please only edit the Progress Report/Ethics Approval Extension page and page 7 of the Application Information page (the attachments page).

What kind of documents can be attached?

• When considering whether to attach documents to the progress report, please note that only documents directly relating to the progress report should be included. Please see BA F1.1.1 Submission requirements checklist for further information.
• Any new safety information (such as a DSUR) should be provided to the HREC via an adverse event/safety report submission after completing the progress report.
• Any updated study information (such as a protocol, PICF or IB update) must be provided to the HREC by way of an amendment following completion of this progress report.

Conflict of interest question (“Provide an update on any conflict of interest changes for the research team in the last 12 months. The changes may be actual, perceived or potential, as per National Statement 5.2.11 or 5.4.”):

• If an actual, perceived, or potential conflict of interest has been declared in your response to this question, please do not update page 6 of the Application Information page with this information yet.
• A note may be included on the progress report approval letter if an amendment submission is required to update page 6 of the Application Information page and what date the amendment submission is due by.
• The amendment submission is required for auditing purposes so that there is a clear record of an amendment to the application which is why the update to page 6 of the Application Information page should not be made on the progress report.

‘Progress Report’ and ‘Ethics Approval Extension’ radio buttons:

• The ‘Ethics Approval Extension’ request radio button should be selected, and the ‘Current Study Close Date’ and ‘New Study Close Date’ filled in.
• However, if a progress report is received with the ‘Progress Report’ radio button selected, Bellberry will edit the form to select the ‘Ethics Approval Extension’ radio button, will enter the correct extension dates and will enter a note on the progress report form to advise that Bellberry has edited the extension dates on the form.

Final reporting key information:

A submission of the final report can only occur after all study activity at a site has finished, including the submission of amendments, protocol violation or serious breach reports, safety reports, and any other correspondence. This generally occurs after the close-out visit (clinical trials) or final reconciliation of study activities (non-clinical trials).

If a Principal Investigator has finished the study at their site, and the progress report is due, and the close-out visit has not occurred, the site must submit a progress report first to ensure that ethical approval does not lapse.

In April QUT (Queensland University of Technology) Faculty of Health held their student excellence awards ceremony.

In 2018 as part of our donations program, Bellberry gave support to QUT with the launch of the 3-year Bellberry Biomedical Ethics student prize.

The winner of the Bellberry Biomedical Ethics prize for the 2021 academic year was Chelsie Lawson. Chelsie said, “It was an incredible surprise and honour to receive this award. It’s so nice to feel recognised for my efforts, and I’m very appreciative of Bellberry for their generosity. It’s a great motivation to keep working hard and make QUT proud”.

Bellberry HREC Chair Dr Jeff Karrasch was at the event to present the award to Chelsie and to pass on Bellberrys many congratulations.

The 2022 ARCS Annual Conference is taking place next week in Sydney. Due to the COVID-19 pandemic, Australians have experienced firsthand how changes can be incorporated into our daily routines in a very short time.  Initially, we came together with a common goal, to survive and manage the pandemic.  We implemented the changes through necessity and valued each other’s input. The next step is to continue this collaboration by understanding that working together with a common purpose benefits all of us. These changes are the results of three key actions: A common purpose, technology as an enabler and stakeholder inclusiveness.

Bellberry are delighted to be supporting and exhibiting at this event. Several members of our staff will be attending including Jerneen Williams, Bellberry Early Phase Clinical Trial Manager, who is a panel member for the ARCs panel session C04: Lessons learnt implementing site electronic systems in clinical research on 25 May at 11.15am.

At a time when the spotlight is firmly on clinical trials across the globe, ACTA is proud to host these annual awards that honour the remarkable Australians who advance our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involved.

The awards include the following 4 categories:

1. ACTA Trial of the Year Award
2. ACTA STInG Excellence in Trial Statistics Award
3. ACTA Consumer Involvement Award
4. ACTA Industry Partnership Award

The ACTA Industry Partnership award is new to 2022 and will be awarded to a collaboration between a commercial entity and a team of academic investigators that have combined to conduct a high-impact clinical trial.

To register for this event please visit the ACTA website here

Bellberry is once again proud to support this event as a premium partner.