Category: <span>Bellberry Community</span>

2023 AAHRPP Annual Conference: Challenge and Change in Charm City

LAST CHANCE FOR EARLY-BIRD REGISTRATION – CLOSES 19 MAY!

Join us at Bellberry’s International Scientific Congress in Adelaide on Friday 23 June 2023:

“Toward a Coordinated Approach for Managing Accelerated Patient Access to Promising Medicines. Balancing Patient, Regulator, HTA, Payer, and Other Stakeholder Needs”

Programme governance by a Scientific Advisory Committee, chaired by Professor Emeritus Lloyd Sansom AO

REGISTER NOW – places are strictly limited.

Bellberry consists of a team of highly professional, innovative and dedicated people who are committed to making a difference within the research community.

Our culture is built on shared values:

• Making a difference
• Working together with integrity and respect
• Professional and Responsive
• Future looking and forward-thinking.

That combination helps our professionals make a difference each day both individually and collectively.

Experienced Professionals

Due to our continued growth we’re excited to share that we currently have the following vacancies:

• Research Officer (part-time) (Melbourne)
• Project Coordinator (part-time) (Melbourne)
• Research Ethics Team Leader (Adelaide)
• HREC Officer (Adelaide)

Please visit our Join the Bellberry Team page for further information on each of these roles and to apply.

Clinical Trials – Quality or Quantity?

Bellberry is further developing guidance with respect to complex study designs (such as platform, adaptive and umbrella protocols), which includes how these applications are presented to our Committees for review.

Aligned to our purpose, the quality of a Bellberry Committee review is part of the foundation of our service. While we acknowledge complex study designs have many advantages, there are additional considerations for the management of these types of study designs, ultimately with the protection of participants in mind.

We encourage sponsors and sites planning a complex study design to reach out to the Bellberry team to discuss their application ahead of submission. If you have any queries please contact our team at bellberry@bellberry.com.au

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

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:

Bellberry delivers high quality, timely, professional HREC (Human Research Ethics Committee) services. Our Operations team supports the submission of applications and the delivery of research. The Operations function ensures that Bellberry HRECs can deliver high quality, timely, and consistent research reviews that meet all relevant accreditation requirements. The HREC Officers work closely with the Team Leaders and Operations Manager to deliver a professional, high level support service to our research sites.

We have ongoing opportunities for casual and permanent HREC Officers.

The HREC Officer position description can be found here.

If you wish to apply for this role, please visit the SEEK website.

If you have any queries regarding this role, please contact Athena Seltsikas our HR Business Partner on 08 8361 3222 or email athenaseltsikas@bellberry.com.au.

Bellberry is proud to work with award-winning medical research organisation Linear Clinical Research.

Linear was established in 2010 in WA as part of a vision from the Harry Perkins Institute of Medical Research to provide a purpose built, state-of-the-art, clinical trials facility in the West.

Bellberry has been providing HREC services to Linear since the facility started operating out of the QEII Medical Centre.

To celebrate our relationship, we have created a film highlighting what Linear has delivered to the WA community in bringing world-first clinical trials to the state. Watch the video here.

Bellberry is delighted to share that one of our HREC members, Greg Crawford, was awarded an AM in the Australia Day honours.

Greg is a Senior Consultant in Palliative Medicine and Director of Research & Education, Northern Adelaide Palliative Service; Professor of Palliative Medicine, Discipline of Medicine, University of Adelaide; Chairman, Board of Palliative Care SA and Chairman, Palliative Care Study Group, Multinational Association for Supportive Care in Cancer.

Greg was awarded the AM for his significant service to palliative care and to tertiary education. Bellberry extend our sincere congratulations on this wonderful achievement.

Hello 2022! Bellberry welcome’s in the new year with 3 HREC meetings being held on 5 January.

HREC meetings will be held every Wednesday for the remainder of the year with the exception of Tuesday 25 January (submission date 12 January) when meetings will be held on this date instead of Wednesday 26 January due to the Australia Day public holiday.

Please contact us at bellberry@bellberry.com.au if you have any submission queries or for any other general queries.