Category: <span>Blog</span>

Speakers and delegates at the Health Services Research Conference 2022 are invited to delve into the inter-related themes of resilience, innovation and value, and the role of health services research in embedding these principles into our health systems.

The conference will bring together a variety of disciplines including medicine, allied health, nursing, health policy, health economics, public health, health promotion, epidemiology, informatics and sociology to share how research can help build and maintain resilience, innovation and value within health systems.

Bellberry are delighted to be the Consumer Engagement Sponsor for this event and we look forward to seeing you there.

HREC meetings are held every Wednesday for the duration of 2023.

Bellberry are proud to be a silver sponsor of the ACTA ASM 2022 being held at the SAHMRI in Adelaide on 7-8 November.

The ACTA ASM will be held on Tuesday 8 November with the theme – Implementing Evidence into Practice: how do we plan, engage and act to ensure our trials have the greatest impact and change practice. The ACTA ASM will also include a day of workshops on Monday 7 November.

Please visit the ACTA website for further programme information. We look forward to seeing you there!

Join us at Australia’s largest Life Sciences Conference, AusBiotech 2022, 26-28 October 2022 in Perth. This year’s programme gives local and international industry leaders the opportunity to recharge, re-energise, refresh and build relationships.

Bellberry are delighted to be supporting and exhibiting at this event. We look forward to seeing you there!

Bellberry are proud to be platinum sponsors of the AAHMS Annual Meeting taking place next month in Melbourne. The flagship Academy event will bring together Fellows, Associate Members and key stakeholders from across Australia to share ideas, welcome the Academy’s new Fellows in 2022 and celebrate outstanding achievements of researchers in the health and medical sciences.

The theme of this year’s meeting is “Future health and transforming technologies”. International and Australian health and medical sciences experts will present on a range of topics and explore new ways to deliver effective, scalable and sustainable initiatives to benefit the health of all Australians.

We look forward to seeing you there!

The months ahead see a busy program of conferences for the team at Bellberry, starting next week with SALHN (Southern Adelaide Local Health Network) Research Week running 26-30 September 2022.  Bellberry and CT:IQ will be exhibiting at a booth on Friday 30 September. We look forward to seeing you there!

Details about the week’s program can be found in this link.

HREC meetings are held every Wednesday for the duration of 2023.

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.

On International Clinical Trials Day last Friday, the Bellberry team supported and acknowledged all the amazing achievements that result from clinical research by hosting a clinical trials themed afternoon tea.

We were also proud to publish the Bellberry Clinical Trial Activity summary report which describes research activity overseen by Bellberry HRECs through 2021. This second annual publication represents a significant proportion of the Australia wide CTN trial activity across the development lifecycle. It demonstrates capability and capacity in a broad range of research areas. The report also captures the originating funding location for inward investment in Sponsored clinical trials, again demonstrating Australia’s active participation in the global development process.

Click here to register and download the Bellberry Clinical Trial Activity Report 2021

Afternoon tea was provided by our Operations Manager Trina O’Donnell:

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.

From a national pool of exceptional collaborative, multicentre, investigator-driven, and impactful trial nominations, four major awards were presented on Friday 20 May for trials demonstrating significant and positive impacts for patients.

The ACTA Clinical Trials National Tribute and Awards were established in 2016 to highlight the outstanding Australian achievements that advance clinical practice and save or improve the lives of patients every year.

The 2022 ACTA award winners were:

Winner – ACTA Trial of the Year Award
REMAP-CAP: Randomised, Embedded, Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia This trial employed a novel design to simultaneously evaluate potential treatments, and efficiently and rapidly generate evidence, which had a significant impact on the care of critical patients during the COVID-19 pandemic.

Other award winners are as follows:

Winner – ACTA STInG Excellence in Trial Statistics Award
The PADDI Trial: The Perioperative Administration of Dexamethasone and Infection – The PADDI Trial This trial presented that dexamethasone can be safely administered to patients to prevent nausea and vomiting when undergoing surgery, without concern about wound infections.

Winner – ACTA Consumer Involvement Award
EMPOWER-SMS: Text messages to improve women’s self-efficacy, quality of life and health outcomes after breast cancer treatment: EMPOWER-SMS randomised clinical trial This trial evaluated the reach and usefulness of a lifestyle-focused text message intervention to support women’s mental and physical health after breast cancer treatment.

Winner – ACTA Industry Partnership Award
Better Knee, Better Me: Effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – a randomized controlled trial This partnership, between the University of Melbourne and Medibank, saw the design and evaluation of two new programs for people with knee osteoarthritis, which were highly rated by participants and health professionals for their effectiveness, simplicity and convenience.

ACTA CEO, Dr Stewart Hay shared: “The caliber and breadth of our 2022 award winners and nominees illustrates the expertise, experience and enthusiasm for conducting clinical trials in Australia. As an industry body, ACTA is committed to supporting and advocating for trial teams to ensure they can continue their great work in providing the community with access to life-changing trials. These awards provide yet another reminder why our work is so important for the sector and patient care.”

Visit the ACTA website for full details of this year’s winners.

On International Clinical Trials Day, we’re proud to publish the Bellberry Clinical Trial Activity Report 2021. This second annual publication represents a significant proportion of the Australia wide CTN trial activity across the development lifecycle. It demonstrates capability and capacity in a broad range of research areas. The report also captures the originating funding location for inward investment in Sponsored clinical trials, again demonstrating Australia’s active participation in the global development process.

In this reporting period Bellberry was also delighted to become the first Australian organisation to achieve accreditation by the global Association for the Accreditation of Human Research Protection Programs (AAHRPP).

If you have any questions relating to this data, please contact us at bellberry@bellberry.com.au

Click here to register and download the Bellberry Clinical Trial Activity Report 2021

Nurses and midwives, are you currently working in clinical research or wanting to start a career in clinical research? Then this is an exciting opportunity for you!

PRAXIS Australia promotes the understanding and practice of ethical human research in Australia and internationally, to enhance the welfare of research participants and the quality and effectiveness of research. Bellberry, the founding partner of PRAXIS, is pleased to again partner with PRAXIS to fund a scholarship supporting five nurses or midwives through a high-quality training package.

This is in recognition of founding PRAXIS CEO, Melanie Gentgall, who joined Bellberry to explore and establish this education initiative and was the energetic custodian who oversaw its transformation into the independent not-for-profit PRAXIS that you see today.

If you are a nurse or midwife wanting to strengthen your knowledge and skills, this is a fantastic opportunity!

Submit your application via the following link https://www.surveymonkey.com/r/7S3GNF9 or QR code below:

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.