Category: <span>Bellberry Community</span>

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”.

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

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.

We were delighted to welcome two new HREC Officers (HO’s) to the team recently. Pam Sim and Sav Perera joined us in June. Both Pam and Sav have studied in the science area and are a welcome addition to our growing HO team.

We are also excited to welcome Helen Daykin and Jo Carino to the team. Helen will be providing administration support to our EPCT team. She brings a wealth of knowledge and experience from within the clinical trials sector, having managed the Adelaide Cancer Centre for many years.  Jo Carino joined the Quality team this month as Quality Team Leader. Jo holds a Bachelor of Science (Honours in Chemistry) and has worked with Mayne Pharma for over 25 years.

Elsewhere in the team, HREC Officer Phoebe Manuel has been seconded to work with the Quality team until January 2022 and Tess Penglis has moved from the Quality team to a new Training Officer position within the Corporate Services team. Our many congratulations to both Phoebe and Tess on their new roles.

Many congratulations to all staff on their new roles.

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/

In light of the recent COVID developments both in SA and across Australia, we’d like to take this opportunity to remind you that Bellberry is available as always to support and assist you in your HREC submission. If you have any questions regarding amendments that need to be made to your study in response to COVID developments, or any other study-related queries, please contact bellberry@bellberry.com.au.

See our COVID-19 Updates page for useful information on pandemic planning tips and our COVID-19 FAQ’s:

https://bellberry.com.au/covid-19-updates/

Bellberry provides the following documents relating to applications that involve radiation:

BA G13 Ionising Radiation
This guidance outlines the requirements where research applications involve the use of ionising radiation.

BA F13.1.1 Standard clauses – ionising radiation
This form provides sites with example clauses for inclusion in the PICF.
If the medical imaging used is the same as standard care.
If extra, study-specific medical imaging is undertaken.
If there are no perceived benefits from participating.

BA F13.1.2 Standard imaging – definitions
This form provides sites with wording to describe different forms of standard imaging for inclusion in the PICF. Imaging covers CT, MRI, and PET scans.

BA F13.1.3 Standard of care declaration – template
Bellberry does not mandate the completion and submission of this form when a PI has made a standard of care declaration in the eProtocol application. If your institution requires the PI to provide a formal notification, please use BA F13.1.3 as a template and place it on your institutional letterhead. This template can be helpful if the PI needs to amend their standard of care declaration during the study.

BA F13.1.4 HREC reporting flowchart – radiation
This form shows the role and relationship between the PI, the HREC and the Medical Physicist when research involves the use of radiation. It also outlines how sites should present the radiation wording to the HREC within all 3 PICF pathways.

Bellberry has also updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist. Full details can be found here.

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

Not-For-Profit and philanthropic leaders have been recognised and celebrated for their service to the community in this year’s Queen’s Birthday Honours List. Charity, humanitarian and philanthropic leaders shone through for their continued tireless work for the community despite the challenges they have faced.

Bellberry is delighted to share that two of our HREC members have been recognised on the 2021 Birthday Honours List and awarded Member (AM) in the general division in the Order of Australia.

Emeritus Professor James Toouli has been recognised for significant service to tertiary medical education, notably to gastroenterology. Jim is Professor Emeritus of Surgery at Flinders University and has been a Bellberry HREC chair since 2012.

The Reverend Dr Cecilie Lander has been recognised for her significant service to neurological medicine and the Anglican Church of Australia. Cecilie is a Clinical Associate Professor in Neurology who has worked in private practice and at the Royal Brisbane & Women’s Hospital for over 40 years. Cecilie was ordained Priest of the Anglican Church of Australia in 1996 and has served as a Bellberry HREC member since 2014.

Bellberry extends sincere congratulations to both Jim and Cecilie on this honour.

Bellberry is delighted to share that one of our HREC Members, Professor Ian Olver, has been awarded the NHMRC ethics award for his significant contribution to Australian health and medical research ethics over the last decade.

Further information on the award and other award recipients can be found on the NHMRC website.

Ian’s background to his involvement in the ethics scene in Australia can be found on the NHMRC website here.

Many congratulations to Ian on this well-deserved recognition.

The ARCS conference earlier this month was a resounding success. Bellberry representatives Alison Barr (Quality Manager), Chloe Shard (Team Leader), Reuben Jacobs (Manager for Business and Strategic Projects) and Jerneen Williams (EPCT Manager) all attended and ‘manned’ the Bellberry booth. They were delighted to meet so many new faces and talk about our HRECs and also catch up with so many familiar faces!

CT:IQ also attended the conference and CT:IQ’s Programme Director, Leanne Weekes said “It was a wonderful opportunity to share information about our projects to everyone who stopped by the CT:IQ booth”. Leanne was part of a panel session discussing, ‘How eConsent is being used in Australia to support clinical trials’.

The ARCS conference was particularly special for Bellberry this year as our CEO Kylie Sproston was awarded the 2021 ARCS MTP Sector Awards Innovation award! Many congratulations to Kylie and the whole BellBerry team on this wonderful achievement.