Category: <span>Quality Activities</span>

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!

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.

Bellberry Biomedical Ethics Prize winner Chelsie Lawson with Bellberry HREC Chair Dr Jeff Karrasch

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.

Prof Anne Kelso and The Hon Brad Hazzard MP present the ACTA Trial of the Year Award to Dr Lisa Higgins, Monash University.

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.

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:

 

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.

The Trustees of the Sylvia and Charles Viertel Charitable Foundation have announced two classes of research grants to be awarded in 2022 and commencing in 2023.

Senior Medical Research Fellowship

The Senior Medical Research Fellowship are intended to be amongst the most prestigious awards available to those who wish to continue a career in medical research in Australia. The Fellowship is an integral part of a scheme that is intended to provide both salary and project grant support for outstanding Australian medical researchers. It has a five-year tenure at $275,000 p.a. for a researcher from any discipline in medical science to be awarded in 2022 and commencing in 2023.

Viertel Clinical Investigator awards

$90,000 is available for a clinical researcher who has recently completed their clinical and research training and is commencing their first substantive appointment (appointment of 5 years or more) clinical position or has been in such a post for no more than 36 months on 30 April. Up to five awards available this year.

The Foundation intends to award at least one (1) award to an eligible female candidate in both classes. Only Australian nationals or permanent residents are eligible for these awards.

A reminder that the closing date for both awards is 30 April 2022.

Further information, including eligibility requirements and application forms, is available from The Viertel Charitable Foundation website

 

We are delighted to congratulate our CEO, Kylie Sproston, on her election as a Fellow of the Australian Academy of Technology and Engineering (ATSE).

Kylie was elected by her peers along with 26 other candidates for 2021 in recognition of a life-long pursuit of excellence through applied science, technology and engineering.

Chair of MTPConnect, Sue MacLeman said she nominated Kylie because of her leadership in the Australian medical research sector, as well as her role at Bellberry. “Kylie was a strong candidate given her significant contribution to the sector and the work she does more broadly including chairing the CRC Advisory Committee, mentoring our clinical trial researchers and providing leadership,” said Ms MacLeman.

“I think she will provide wonderful skills and expertise to ATSE and will have a real impact participating in policy responses in health and other areas.”

ATSE said the 2021 Fellows “inspire us to be bold, ambitious and progressive in how we use technology to tackle some of our most urgent challenges from COVID-19 to climate change”.

Bellberry is proud to be the premium sponsor of this years Australasian Pharmaceutical Science Association (APSA) annual conference.

The APSA Annual Conference will bring together international and national academics and researchers in the fields of pharmaceutical science, clinical sciences, pharmacy practice, and pharmacy education.

The program will showcase the latest scientific research in each field and offer attendees the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the conference will be the chance for early career researchers and students to present their research findings in poster and oral presentation sessions. APSA’s annual awards and prizes will also be presented during the conference.

The virtual conference will take place from 6-8 December. Please click here to register for this event.

Bellberry is proud to be the principal sponsor of the ASCEPT annual scientific meeting taking place virtually next week.

The ASM offers the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the ASM is the chance for early career researchers and research students to present their research findings in poster and oral presentations sessions. ASCEPT annual awards and prizes will also be presented at the ASM.

The program of plenary lectures, symposia and workshops, oral presentations and posters look to be scientifically stimulating. We look forward to seeing you online!

As per the National Statement on Ethical Conduct in Human Research (2007) Updated 2018, at the end of each HREC meeting, Bellberry Administration creates a ‘Member List’ as per the example below:

The member composition at the meeting may change from protocol to protocol, in consideration of the expertise required and conflicts of interest. The list is saved on page 7 of your eProtocol application and represents the membership for your protocol.

As outlined in CG P8 HREC Terms of reference, Bellberry does not issue the names of individual HREC members to external parties.

If you have any queries regarding the HREC membership list please contact Bellberry@bellberry.com.au

Bellberry is delighted to once again be a session sponsor at Bio Connections Australia. Bio Connections Australia explores drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialization. 2020 saw significant disruption to the drug development and clinical trials landscape in Australia and around the world and the research community are keen to reconnect, network, and learn. Bio Connections are excited to be moving back to in-person events but will continue to offer the option to attend the event virtually.

Jerneen Williams, Bellberry Early Phase Clinical Trial Manager will be attending this event and is also a panel member for the session titled ‘Delivering quality and efficiency in Australia’s clinical trials and addressing the resourcing challenge’. Please join Jerneen at this key event!

 

As most of our users have now formalised local governance processes for internal safety reporting, we have updated MAR G2 Safety reporting, to no longer require the submission of SUSARs for individual events at Bellberry sites.

To assist sites in understanding the updated requirements, if Bellberry’s administrative team receives documentation not outlined in MAR G2, a reference will be made to MAR G2, and the submission returned.

General advice to sites regarding submissions:

If your study is multi-centre, please ensure your submission considers the participants at all centres.

For example:
•   There is a halt in recruitment due to drug supply issues in Australia. The Sponsor has confirmed there will be no supply for three weeks.

Example wording for the site submission:
Our site is awaiting governance sign off and has not recruited any participants. We will not recruit until the halt is lifted.
Dr Peters (site AA) has recruited one participant, and they have enough study drug to last their participant for 6 weeks. If there is any update to the supply issue that puts this participant at risk, we will notify the HREC.

•    If the urgent safety measure includes a request to inform participants of a safety issue:

Example wording for the site submission:
Our site has four active participants. Prof Barnes (site AA) has two participants. All were phoned and told of the safety event and documented in their notes. No participant had any further queries on the matter.

If your study includes a caveat and you are attaching documentation in relation to the caveat, please ensure your submission details the purpose of your attachments.

For example:
•    The caveat on the initial approval letter requests the following “Please submit correspondence from the DSMB during Part A of the trial. Part B cannot proceed until the HREC has reviewed the DSMB letters and an updated PICF and protocol is approved”.

Example wording for the site submission:
The attached DSMB letters refer to the caveat from the HREC on the initial approval letters that all correspondence must be submitted during Part A of the trial. Once the safety letters are acknowledged, the site will submit an amendment for Part B with an updated PICF and Protocol for HREC consideration.

The ‘AER’ safety reporting pathway questions will be updated in eProtocol in due course. Until then sites are welcome to select option 2, ‘Summary report’ for all submissions, as the relevant information regarding dates of events should exist in the attachments.

Please take the time to reflect on the updated reporting requirements and how this will impact your local procedures.

If you have any queries regarding these changes please contact Bellberry at bellberry@bellberry.com.au

Registrations are now open for the virtual 2021 ACTA Annual Scientific Meeting!

Bellberry is delighted to once again sponsor the ACTA Annual Scientific Meeting. This year’s meeting will focus on Strengthening the pipeline for clinical trials. At a time when the spotlight is firmly on clinical trials across the globe, there has never been a more critical time for our sector’s leaders and consumers to come together to share knowledge, experiences, challenges, and opportunities for change.

The 3-day event will be held online from 10 – 12 November 2021. Further details can be found on the ACTA ASM website.

Progress reporting realignment initiative

We have seen significant improvement with compliance since Bellberry began a significant progress reporting realignment initiative. The primary objectives of the project were to:

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).

BA G16 eProtocol navigation guide for researchers

This guidance provides a comprehensive list of questions asked via the eProtocol application forms. These forms have been updated to include what researchers should consider when preparing responses to progress and final report questions. Researchers may use these forms to prepare responses before submission to eProtocol.

Progress reporting key updates:

Each Principal Investigator is responsible for submitting an annual progress report relating to study activities at their site. Responsibility should only be delegated to site staff with appropriate understanding of site-based activities. Reporting opens within 30 days of the due date. Progress reports submitted outside of earlier than this time frame will be returned.

Often sites require submission of amendments and progress reports in a similar timeframe. eProtocol does not allow concurrent submissions of amendments and progress reports. To ensure that continuous ethical approval is maintained, where a progress report is due to be submitted (i.e. within 30 days of the due date) and an amendment is also required (e.g. protocol/IB update), the site must:

  1. Submit the progress report*.
  2. Phone or email bellberry@bellberry.com.au to request expedited review of the progress report
  3. Submit the amendment immediately post progress report acknowledgement.
  4. When applicable, please phone or email Bellberry to request urgent processing of progress reports preventing an amendment submission.

*When considering whether to attach documents to the progress report, please note that only documents directly relating to the progress report should be included. Any other documents must be submitted by the appropriate pathway (e.g. an amendment, safety, or serious breach form) as these reports are categorised and reviewed according to the extent and impact of any changes. Please see BA F1.1.1 Submission requirements checklist for further information.

If any discrepancies are identified when completing the progress report, the researcher should:

  1. Note the disparity in the appropriate question field in the progress report before the progress report is submitted.
  2. Provide the HREC with the relevant documentation through the appropriate pathway immediately post progress report acknowledgement (e.g. submission of an amendment, safety, or serious breach form).

Final reporting key updates:

If a Principal Investigator has finished the study at their site, and the progress report is due, and the closeout visit has not occurred, the site must submit a progress report. Once the closeout visit occurs, any outstanding correspondence identified as requiring submission is to occur by the appropriate channel (e.g. amendment, safety, serious breach) before submitting the final report to the HREC.

If you have any questions or queries regarding these updates, please contact the Quality Team at quality@bellberry.com.au.

We are delighted to announce that Bellberry-Viertel Fellow Prof Di Yu has been recognised by the Australian Academy of Health and Medical Sciences’ (AAHMS) with the Jian Zhou Medal. The Jian Zhou Medal is awarded to scientists working to battle breast cancer, autoimmune and infectious diseases who have been recognised for their outstanding discoveries.

Professor Yu was awarded in recognition of his landmark discoveries in revealing the differentiation and functions of T cells in human health and disease, research which has enabled new diagnosis and therapy for autoimmune, allergic and infectious diseases, and the improvement for vaccine efficacy.

Further information and details of the other award recipient can be found on the AAHMS website: https://aahms.org/news/scientists-honoured-with-jian-zhou-medals/