Category: <span>Blog</span>

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.

The Academy’s 2021 Annual Scientific Meeting will be delivered online over two half days, where invited international and national presenters will explore and discuss ‘The impact of research’.

Click here for the full event program

Join Bellberry throughout AusBiotech 2021. The week includes:

• A week of interactive online programming, accessible live and on-demand for a further 30 days

• International and national keynote speakers

• Expert panel discussions

• The AusBiotech and Johnson & Johnson Innovation Industry Excellence Awards 2021

• A week of virtual AusPartnering, AusBiotech’s business matching programme

• Networking lounge to engage, make new contacts, and exchange thoughts in randomly-allocated virtual rooms

• Early-Stage Investment Forum

• Opportunity to connect with industry through our BioIndustry Company Profile platform

• MORE VALUE ADDED: Access to Australia’s preeminent life science investment event Australia Biotech Invest & Partnering 2021.

Registration is open now!

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.

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:

• 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-MM 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).

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.

This month the White Coats Foundation are launching a two-part webinar series titled ‘De-Mystifying Consumer and Community Involvement in Research.‘

The White Coats Foundation looks at “de-mystifying” consumer and community involvement in research via a two-part webinar series that aims to:

• Provide clarification on what “consumer and community involvement” in research means.
• Provide insight into the training options available to support consumers with basic skills and knowledge to effectively engage in research.
• Explore the barriers to consumer engagement.
• Explore pathways that can facilitate the connection between researchers and consumers. These avenues are underdeveloped and need to be reviewed.
• Explore feedback mechanisms to consumers on outcomes of involvement and ensure participation is value-adding.

The two sessions will be held on Weds 15 and Weds 22 September.

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.