Category: <span>Bellberry Community</span>

The 2020 ARCS Virtual Summit brings together industry, regulator, academia and researchers to educate, network and unite in a time of change. It will provide essential and timely information in each of the key educational areas – particularly as we traverse the issues associated with the COVID-19 pandemic as well other local and international issues. One of the benefits with a virtual event, is the ability to invite a strong and compelling line up of international speakers providing a global perspective.

This virtual event will comprise a series of streams over the week. A set of sessions on a topic area becomes a stream. Delegates can select a stream and, over the week, attend 5 sessions at the same time daily with a different topic each day. This way attendees do not need to commit for a whole day but still feel like being involved in a virtual conference-style event.

Bellberry will be online at this event so please join us!

Register Now

The last meeting of 2020 will be held on Wed 23 December with a submission deadline date of Wed 9 December. The first meeting of 2021 will be on Wed 6 January with a submission deadline of Wed 16 December.

The Bellberry office will be closed from COB on Thurs 24 December until Mon 4 January at 9 am. There will be no HREC meeting on Wed 30 December.

Meeting Date     Submission Date

Wed 23 Dec            Wed 9 Dec
Wed 6 Jan              Wed 16 Dec
Wed 13 Jan            Wed 23 Dec

Meetings will continue to be held every Wednesday for 2021 with the submission date 2 weeks before the meeting date.

Bellberry is committed to ensuring the privacy and security for users of our service. In light of recent government announcements warning of increases in cybersecurity attacks, Bellberry has assessed its current processes relating to eProtocol registrations and have made the following changes to strengthen our current security procedures.

All new eProtocol registrations will be required to submit an Organisational Verification of Personnel form (OVOP BA F2.1.3). This form replaces all previous authorisation forms, and its purpose is to verify the new applicant’s affiliation to the organisation/site with which they are registering. Each site will need to appoint an authorised representative that will sign off each new registration for their organisation on the OVOP form.

What is an authorised representative?

Each organisation must have a dedicated person(s) that assumes responsibility for the authorisation of new personnel registering for eProtocol access from that organisation. The authorised representative should be known by staff as they will need to verify the applicant as part of the registration process.

Larger organisations may choose to delegate this role to a departmental level, e.g. a hospital may select the Clinical Trials Manager in each department. For stand-alone clinics, it may be the practice manager or Principal Investigator. The organisation is responsible for determining the person responsible and declaring this person to Bellberry. Bellberry will maintain a register of authorised representatives, and each new registration for that organisation will be verified with the nominated representative.

Sites and sponsors will notice the change to new registrations from August 14 2020. There will be no change for existing registrations.

For any eProtocol registration related questions, please contact our HREC Co-Ordinator, Alison Branford, on (08)  8361 3222 or via email bellberry@bellberry.com.au.

Related documents

For comprehensive guidance on Bellberry’s eProtocol registration requirements, please see BA F2.1.3 Organisational Verification of Personnel form

Disruption, adaption and adoption

The COVID-19 pandemic has rapidly transformed much of the clinical trials and associated medical device, pharmaceutical, and vaccine industries in Australia and internationally.

What’s next for the world of clinical research as we learn to adapt to the changes which are likely to remain with us long term as a result of the Covid19 pandemic?  

Sponsors, contract research organisations, and sites are now focusing on returning to full capacity. Changes in practice mean that “business as usual” will be disrupted. Many positive changes will arise – and that’s a significant positive outcome arising from the pandemic, but what does this mean for our usual practice? 

During this webinar hosted by PRAXIS Australia, we will hear from sector leaders who will address ethical, practical and clinical implications relating to the new health and safety concerns for patients and employees and learn about their experience with solutions to those problems, such as telemedicine/telehealth, direct-to-patient approaches, and implementation of new site level technology to ensure safety measures are properly in place.

Date: 20th August
Time: 11am – 12:30pm AEST
Price: Free of charge

Facilitators: 

Other panellists: 

COVID-19 FAQ

As Bellberry’s position has changed significantly since 2020, please direct your COVID-19 queries to bellberry@belberry.com.au. We’re here to help. Based on feedback from sites and sponsors, and in our aim for continuous improvement, Bellberry has made further attempts to streamline progress reporting. The change in reporting will make it easier for sites and sponsors to control and manage the due dates for progress reports and consolidates the two processes of progress reports and extension (PRE) requests to occur at the same time. Bellberry has moved to one-year terms of approval for all studies approved from 29 April 2020. The DD-MM cycle of the lead site will determine the due date for PRE submissions, with an exception to sites approved within 60 days of the due date. 60-day exception rule explained below: The following will occur: The guidance sent to sites in early 2020 stated the changes would not impact older studies. This advice has changed. Please continue reading. Many studies have two, three, and five-year terms of approval. When extension requests are submitted for studies approved before April 29, 2020, they will move to the one-year term of approval. Often, sites have a different term of approval expiry to their progress report due date. These dates will be realigned, and all sites will move to the reporting cycle of the lead site. For some sites, this will mean a complete change of month and shorter than a one-year term of approval for the next reporting cycle. Date realignment explained below: The following will occur: While the last two sites now have less than six months before their next report is due, it will bring all sites under the one reporting cycle. It also reduces the need to submit a progress report and an extension request as they become the same item. In the event the lead site has closed, the advice does not change. The PRE will align with the initial approval date cycle (DD-MM). Once your site is updated and realigned, all sites will receive a reminder email at 30, 14 and 7 days before the due date. Sites will notice the change to their reporting from June 01, 2020. Related documents For comprehensive guidance on Bellberry’s reporting requirements, please see MAR G4 Progress and final reports, available at the Bellberry website: monitoring approved research

Bellberry awarded AAHRPP accreditation

Bellberry has become the first organisation in Australia to achieve international accreditation for excellence and ethically sound processes in running Human Research Ethics Committees (HRECs).

The recognition has come from the Association for the Accreditation of Human Research Protection Programs (AAHRPP), which is based in the USA. The AAHRPP site accreditation team visited Australia to conduct an extensive review of Bellberry’s operations earlier this year.

Bellberry’s CEO Kylie Sproston has welcomed the news.

“This is a huge boost at a time when Bellberry is firmly focused on the safe continuation or adjustment of current clinical trial activities and the welfare of participants on those trials,” Ms Sproston said.

Elyse Summers, CEO and President of AAHRPP said that AAHRPP’s Council on Accreditation (Council) met (remotely) and awarded Bellberry full AAHRPP Accreditation.

“The site visit team and Council were highly impressed with Bellberry’s robust human research protections program (HRPP), which serves as an excellent model in Australia for the ethical review of and education about research involving human participants,” said Ms Summers.

Ms Sproston said, “The accreditation is testament to all the hard work undertaken by our staff, the broader Bellberry team, our HREC Community, and the researchers that we serve”.

The primary purpose of AAHRPP accreditation is to strengthen protections for research participants. However, the benefits of AAHRPP’s comprehensive approach extend beyond participants to the research enterprise as a whole. Each accreditation advances that objective and helps build public trust and confidence in research.

Long regarded as the gold standard, AAHRPP accreditation is becoming the norm for quality research programs in the US. All major U.S. independent institutional review boards (IRBs) are AAHRPP accredited. More than 60 percent of U.S. research-intensive universities and 65 percent of U.S. medical schools are either AAHRPP accredited or have begun the accreditation process.

AAHRPP-accredited organisations have been recognised to have more efficient operations, provide more comprehensive protections, and produce high-quality data. AAHRPP-accredited organisations also tend to have more streamlined, effective policies and procedures.

AAHRPP recently published their May newsletter which includes an article on Bellberrys accreditation: https://www.aahrpp.org/

Perth based not-for-profit clinical trial facility, Linear, got early warning on the seriousness of COVID-19 thanks to a staff member who was visiting China and staying in the province next to Hubei. The trained nurse who is the Head of China Business Development for Linear, not only played a crucial role in alerting the organisation about the rapidly developing situation in Wuhan, but also managed to secure 400,000 N95 medical masks for her state of WA from China. This is a neat illustration of what Linear’s CEO, Jayden Rogers, believes has put Linear in a good position to deal with the challenges presented by COVID-19. For him it’s all about the people and long term investment in innovation and culture. “The true north for us, when COVID first hit, was always going to be to protect our volunteers and staff, that was going to be the key to all the decisions that our teams made,” he said. “I think the reason it has worked so well is because of our investment in our people. And that’s not something you can just turn on, we put a lot of effort into training and development and recently people have shown how agile, adaptable and flexible they can be when change is coming at a rate of knots.” Putting volunteers and staff first meant reducing capacity on healthy volunteer trials. This resulted in less people undertaking trials so participant safety could be ensured. A number of healthy volunteer trials were slowed down or delayed. This had to be communicated to sponsors, but overwhelmingly they have been supportive of Linear’s approach. A strong focus was placed on those undertaking trials who were vulnerable. “We have some very vulnerable patient groups in our clinic, we engaged very closely with specialists and the patients to understand the risks that COVID presented to them. In many cases these patients (for instance on oncology trials) are in such a challenging situation that the risk of not being able to access a trial is worse than the risk of COVID itself.” With that in mind, Linear doubled down to protect vulnerable patients, by effectively locking down the clinic well before the practice became common, and before any domestic or international travel bans were put in place. A reduction in the overall capacity of the clinic was put in place as well as the creation of separate trial zones. Distancing between each clinical trial participant occurred by leaving an empty bed between each participant. Staff teams were divided up and worked separately to ensure participant safety. “Thanks to our investment in technology we could move to remote monitoring, which means that only the people who must be in the clinic are there. We made the tough decision with our patients that family members couldn’t accompany them unless absolutely required. And we could get a majority of our staff working from home very rapidly.” Another reason to continue trials for vulnerable patients was to help them stay out of hospital so that more beds are free for anyone who may get infected with the virus. For Linear it was vital to be well across the local situation in Western Australia. A local private company was engaged to undertake COVID-19 screening for Linear’s clinic, but only once it was established that this was not going to impact supply of COVID-19 tests for the state authorities. “The testing has given us another tool in our arsenal of screening assessments to give us a higher level of comfort that we are unlikely to have anyone in the clinic who is positive to COVID-19,” said Jayden. “We also engaged very early with the Sir Charles Gairdner Hospital and the wider medical community in terms of what we could do around the broader response to COVID-19. We brought in experts such as infectious disease and emergency medicine specialists to evaluate what we were doing. That was really helpful and gave us a lot of comfort on the processes that we were putting in place.” But Jayden is keen to point out that it’s not just Linear that is going above and beyond when it comes to responding to COVID-19. He believes that the whole sector across Australia is doing good work as well as the authorities. However, we are at the beginning of a long battle. Linear has a planning ahead team for COVID-19 as well as a COVID-19 team that meets daily. “It’s about continuing to innovate and find ways not to just cope with it, but to fight it. That’s been part of our mantra. It’s a psychological battle as much as it is an infectious disease. So it’s important to fight it in as many ways as possible. I think we are privileged in some ways to work as an industry that is at the heart of that fight.” While acknowledging that the sector as a whole is doing great work in dealing with the challenges of the pandemic Jayden has three tips that have helped steer Linear’s course ahead of the curve.
  1. Ongoing investment in people, culture and technology is crucial
  2. Listen to what the data is saying and move quickly
  3. Communication is key with all stakeholders including trial participants, staff, investigators, sponsors, institutions, suppliers and authorities
Linear has recently announced it will be an Australian testing site for a COVID-19 vaccine and has put a call out for healthy volunteers. (Interview and article on behalf of Bellberry by Alison Rogers, Living Stories)
For more information about practical adjustments to modify Clinical Trials for the COVID-19 period please refer to: For queries and support,  please contact the Bellberry team via 08 8361 3222 or covidsubmissions@bellberry.com.au

ACTA, PRAXIS, ARCS and CT:IQ collaborate to host clinical trials online forum launching on International Clinical Trials Day, 20 May 2020

Australian Clinical Trials Alliance (ACTA), PRAXIS Australia, ARCS Australia and CT:IQ have come together to create Beyond COVID-19: a solution-focussed forum after identifying a need for the clinical trial sector to collaborate and share information.

Beyond COVID-19: a solution-focussed forum is an exciting new initiative for people working in clinical trials to share their learnings and assist with solutions.

It will be open for anyone to read, and registration to participate is simple. Clinical trialist’s can instantly share their knowledge, assist with responses and point each other to useful resources or contacts; from ethics to telehealth, pharmaceutical supply to remote monitoring. Solving problems is at the heart of clinical trials, and the COVID-19 pandemic has seen the sector becoming more agile; adapting existing trials, finding new ways to commence planned trials, or moving quickly to help test treatments and solve the riddles of coronavirus.

The pathway out of the pandemic will also see some twists and turns and more problem-solving for the sector, where the Beyond COVID-19: a solution-focussed forum will continue to be a sharing space.

Join us all at 1:30 pm AEST on International Clinical Trials Day, Wednesday 20 May, for the official launch of Beyond COVID-19: a solution-focussed forum.

A guest panel of experts will be live on the forum for the launch to offer their perspectives on your questions about clinical trials through COVID-19 and beyond.

Please register beforehand – today.

The forum will be hosted at clinicaltrialsalliance.org.au/forums/

#clinicaltrials #COVID19 #BEYONDCOVID19

Report of an international workshop convened by Bellberry, held on November 18-20, in Sydney, Australia

In November 2019 Bellberry were delighted to host the “Challenges of Valuing and paying for Combination Therapies in Oncology” international workshop in Sydney.

This event brought together over 50 experts from around the world from a range of stakeholder groups to discuss the challenges associated with valuing and paying for combination regimens in oncology. All aspects of the workshop programme were overseen by a Scientific Committee and were chaired by E/Prof Lloyd Sansom.

The workshop was followed by a one-day open day meeting where the deliberations and conclusions of the expert panel presented and debated amongst a wider local audience.  The workshop outcome was the development of an agreed statement of good practice, guidelines on approaches and a clear agreement on any required next steps.

The full workshop report can be viewed here

To assist and guide you through this challenging time, Bellberry will continue to gather, distil and deliver the latest information relevant to the oversight of clinical trials during the COVID-19 pandemic.

We will be providing new information as it becomes available. Click here to access the latest information https://bellberry.com.au/covid-19-updates/

Earlier this week Bellberry CEO Kylie Sproston joined Tam Nguyen (St Vincent’s Hospital Melbourne) and James Cokayne (NSW Health) to speak at one of ARCS Australia’s series of webinars on COVID-19.

The session was entitled ‘Ethics Committees and Governance’ and topics discussed by the panel included how to manage the continuation of the safety and welfare of participants during the pandemic along with tips on how to best manage your trial during this time.

The full webinar can be viewed here.

ENROL NOW!

PRAXIS’s small team has received over 1000 enrolments for these sessions and as such processing of registrations may be prolonged. It’s likely that PRAXIS will need to plan new dates so please visit the PRAXIS website regularly!

Bellberry has been monitoring the development of the COVID-19 outbreak over the last few weeks. As the Australian situation has now moved past the 100 patient point, we would like to share with you information about our planning and services. Research Participant Welfare & Study Changes As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants and to support the continuation of on-going trials. Bellberry has developed a list of suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations.  Click here to download.
Operational HREC Activity The COVID-19 situation has required Bellberry to rethink our Business Continuity Planning, moving from plans that recreate the whole organisation in a new location, to the ways in which we will continue to run our services while the team is wholly dispersed.  We have the technology in place to allow this to happen and have been testing fully remote working techniques over the last 2 weeks.  These tests cover the executive, the administration, and the function of the HREC, along with the heart of the operation: the HREC meeting itself.  We are learning from each series of tests, and are confident that we will be able to continue to offer support and services in the range of possible restricted scenarios ahead. Bellberry has a schedule of 3 HREC meetings per week, and will continue to support these meetings in a way that protects the safety of our HREC members and operational team.
Business Continuity Planning for HRECs and Institutions Around the country, health systems are reprioritising their workloads in anticipation of the scenarios ahead.  In light of that, a number of institutions have contacted Bellberry requesting information about utilising Bellberry HRECs as a Business Continuity backup for their own HREC. Bellberry can provide interim support to institutional HRECs and Research Offices: on a long-term, short-term or ad hoc basis. Please contact Trina O’Donnell, Operations Manager, 08 8361 3222 if you would like more information about this service.
Emergency COVID-19 related Study Reviews Bellberry has experience of emergency, fast-track reviews of pandemic-related studies.  Historically, these reviews have been completed within a few days.  Bellberry HRECs also have the depth of experience with routine infectious disease and vaccine studies, such as seasonal flu and diagnostics. The Bellberry HREC panel includes members with appropriate targeted expertise, including infectious disease, vaccine development, pharmacology, toxicology and immunology.  We have confirmed availabilities in the next weeks and months to allow us to support COVID-19 related developments as emergency reviews. These reviews will be fast-tracked as emergency meetings in addition to the scheduled programme of meetings.  We have received contacts about a number of COVID-19 studies, and will play our part in supporting fast-track development.  Contact Trina O’Donnell, Operations Manager on 08 8361 3222 for more information. Bellberry will continue to monitor the emerging situation and will provide regular updates.  In the meantime, for any questions, please contact the team at covidsubmissions@bellberry.com.au or 08 8361 3222.

Research Participant Welfare & Study Changes

As the COVID-19 situation escalates in a number of jurisdictions around the world and within Australia, many Clinical Trial Sites and Sponsors are considering actions to be taken to protect the welfare of trial Participants, and to support the continuation of on-going trials.

The following are suggested topics for planning purposes. This list should not be considered to be complete, and additional considerations are likely to emerge as the situation continues to develop. Not every topic will be relevant to every trial. They are however intended to be a helpful starting point when considering planning for individual sites and trial situations.

Participant communication
Your participants may be reluctant to attend trial visits in a hospital setting, or to a busy clinical practice, or to use public transport to reach you.  Your participants may have questions about how their trial will continue in light of any local outbreak.  In time, you are likely to have participants placed in self-isolation or quarantine.  Participants will undoubtedly have questions about what the emerging pandemic means for their trial participation.  Consider proactively supporting your participants with an FAQ or a helpline contact.  Establishing lines of communication will assist if further pandemic developments trigger additional changes in the coming weeks.

Access and continuity of supply
Consider how to assure ongoing access to trial products and any other items required for delivery of the trial protocol.  Consider whether participants might need a larger supply of investigational product to cover any period of uncertain access.  Consider whether and how that might be dispensed and delivered in a way that minimises risk to participants. Many sites will hear from Sponsors in the coming days and weeks, as they deploy their pandemic planning. Please speak to the HREC for support with amendments, violations or safety reports.

Protocol amendments or deviations
Where changes are anticipated, reach out early and proactively to discuss these with the HREC.  Some investigators are exploring a reduction in protocol-mandated study visits, use of remote consultations and alternative dispensing.  These can be documented proactively in an Amendment for the HREC to review or may be submitted as a Protocol Violation if more urgent changes are required for the safety of participants.

Possible amendments
As the situation is still developing, it may be appropriate to consider substantial changes for a “what if” scenario that might never occur.  In these circumstances, the HREC will consider scenario planning with anticipated changes, and articulation of when and how you would choose to deploy that amendment.  Bellberry HRECs will work with you to ensure sites can make changes in this volatile and rapidly changing environment. Consider submitting a ‘Plan B’ amendment now so that you’re pre-approved to move to new processes if and when you need to.

Participant monitoring
Consider the continuation of participant monitoring if quarantine or isolation measures are required.  Some sites already make use of remote technologies, which are likely to see broader use in the coming weeks.  If you are considering remote technologies you should check whether that method is appropriate and accessible to all participants.  Speak to the HREC about any amendments required.

Health system reprioritisation
Consider whether any location changes might be needed to support the ongoing monitoring of participants.  In some cases, alternative pathology pathways are being explored, along with alternative pharmacy arrangements.

Site screening and travel restrictions
Daily updates on countries considered at risk can be found at health.gov.au, along with advice for travel screening and access restrictions.  This list is changing frequently, so please ensure that you check in with it often.

Signatures
As the use of remote working takes hold, we are likely to see delays in getting hold of wet ink signatures.  Bellberry supports the use of electronic signatures and would encourage you to consider using them even if you haven’t before.

Pandemic Planning
In rapidly-changing scenarios such as the one facing Australia right now, decisions you make today may be out of date by tomorrow.  Consider putting time aside on an on-going basis to manage changes required as the situation develops.

Quality of documentation and reporting
We anticipate a large number of changes to current practice and approved protocols as this situation evolves.  Bellberry HRECs will support you to process amendments, violations and safety reports as they arise.  In such a rapidly-changing situation, it is critical that you keep good records to support compliant reporting.

Safety of trial participants
Participant safety is always our prime focus.  At a time like this, sites should be prepared to re-evaluate trial activities and discuss individual trial participation if the risk profile changes.

Sites running trials approved by Bellberry HRECs are encouraged to reach out early for support.

COVID-19: Considerations for Clinical Trials (329 downloads ) (printable pdf format)