Category: <span>Blog</span>
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.
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 (330 downloads ) (printable pdf format)
Bellberry is delighted to announce the recent registration and certification of 4 new HRECs H, I, J and K bringing our total number of HRECs to 12. This enables us to support up to 3 HREC meetings per week.
Full details of all our Committee’s can be found on our HREC page.
Early last year Bellberry adopted the Early Phase Clinical Trial (EPCT) reviews for NSW public health sites and during that time submissions have steadily grown. To enable us to support this growth along with organic business growth, we are delighted to announce that we have recently recruited additional staff.
Joining the administration team we welcome 5 new HREC Officer’s: Phoebe Manuel, Anthea Hall, Micheala Singe, Natalie Brown and Ali Young. We also welcome Alison Branford to the new role of HREC Co-ordinator.
Phoebe is a graduate of Pharmaceutical Science. During her university degree, she undertook work experience in a university chemistry research laboratory and at a clinical trials unit and completed a placement at an overseas pharmaceutical company. She also worked in a pathology laboratory for a year as a technical assistant.
Natalie has spent the last 12 years of her career working in administration roles within the medical field and not-for-profit organisations including Reception, Office Management, Operations and Committee Management. Natalie worked at The Australian Medical Association (AMA(SA)) prior to coming to Bellberry.
Michealea has had a varied career across multiple industries including Incident Coordinator, Document Controller and Operations Support Coordinator at a major not-for-profit organisation, Legal Secretary at a federal government agency and Network Service Manager for a national real estate franchisor.
Anthea has come from a background in medical research administration and has an Honours Degree in Health and Medical Science from the University of Adelaide.
Ali is a skilled administration and personal assistant with a background in Commercial Property. Her passion for helping people and dance teaching inspired her to change career path and focus on the medical and health industry.
Alison Branford comes to Bellberry with over 30 years of experience working in the medical industry. She has worked in varying administrative and managerial roles during this time.
The new team members are a great asset to Bellberry bringing with them a wealth of knowledge and a diversity of experience. We welcome them all to the Bellberry community!
Melanie Gentgall, CEO of Praxis Australia, has been shortlisted for Pro Bono Australia’s Impact 25 awards. These awards seek to recognise and celebrate the amazing people delivering incredible outcomes in the Not For Profit sector.
Through Praxis, Bellberry seeks to support education that in turn delivers on our core objectives of improving the quality, efficiency and effectiveness of research and the welfare of research participants. Melanie joined Bellberry to explore and establish this education initiative and has been the energetic custodian that has overseen its transformation into the independent NFP Praxis that you see today.
Bellberry is exceedingly proud of both Melanie and the work of Praxis. If you would like to cast your vote to support Melanie and to recognise her achievements with Praxis, please click on the link below. Voting closes on Thursday 12 Feb.
Bellberry’s mission is to protect the welfare of research participants and to improve the quality, efficiency and effectiveness of research.
Whenever possible, we are always striving to make improvements to streamline the HREC process. To kick off in 2020, please find below an update of the significant changes that will impact research sites and sponsors. These changes will be rolling out in the coming days, weeks and months.
If you have any suggestions for future quality improvements initiatives, please email quality@bellberry.com.au.
Sponsor access to eProtocol
Sponsors and CROs wishing to access studies in eProtocol can now liaise with the site Principal Investigator to obtain access.
- Sponsors can assist with all parts of the application but cannot press ‘submit’. This remains the responsibility of the Principal Investigator.
- Principal Investigators retain control of all persons that they wish to allow access to.
Progress reports
Moving to a one-year term of approval cycle from March 2020.
- Studies approved before March 2020 will remain with current terms and conditions.
- A protocol violation report must be submitted for any progress report that is submitted after midnight on the date it is due.
- All sites urged to review their open studies to ensure their progress reporting is up to date.
Application form
The application form has had some minor question changes.
- Sites need to be mindful of these changes when applying and read all questions carefully.
- Declaration of the Principal Investigator has changed.
Document changes
There are several changes to Bellberry documentation. Many documents that you previously knew as policies are now sitting in an updated structure of Guidance and Resources. Click here for a table of all documents both old and new. This list is not exhaustive; it contains only references to the former policies.
Site monitoring
From 2020, site monitoring will occur in two ways – face to face and via desktop auditing.
- Sites will be given a template to complete for desktop audits.
Institutional responsibilities
By the end of the first quarter of 2020, there will be changes to some documents that Bellberry requests, including site-specific documents.
- We are currently working with pilot sites & sponsors to test the new process and forms.
- Sites are encouraged to spend the coming months preparing for how they will manage their internal document flow, version control and authorisation process.
- These examples relate purely to what documentation is uploaded, and each site is still responsible for creating their own ‘site application’ in the system.
As we entered 2020 Bellberry celebrated the New Year by reaching our 50th submission for NSW Health Early Phase Clinical Trials.
Bellberry HRECs were appointed by NSW Health for the review of adult Early Phase Clinical Trial (EPCT) applications early in 2019. From April 2019, all EPCT HREC trials conducted at an NSW Public Health Organisation (PHO) site had to be reviewed and approved by an appointed NSW Health EPCT HREC.
Many congratulations to our EPCT team for all their hard work in achieving this milestone!
For further information regarding applications or for submission help please visit the EPCT section of the Bellberry website or contact the Bellberry HREC EPCT Manager Jerneen Williams
The Bellberry office will be closed from Tues 24 Dec at 5 pm until Thurs 2 Jan at 9 am.
There will be no HREC meeting on Wed 1 Jan 2020 (public holiday). The first meeting of 2020 is on Thurs 2 Jan.
All remaining HREC meetings for 2020 will be held weekly every Wednesday.
Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently externally advertised and recruited to a number of new roles, several of which have been successfully filled internally.
Member Coordinator
Congratulations to HREC Administrator Molly Wundenburg who has been appointed as Member Coordinator. Molly will work closely with Cathy Stevens liaising with, supporting and co-ordinating over 100 HREC members ensuring that they have all that they need to provide high-quality HREC reviews, along with our ongoing commitment to the recruitment of new members.
IT Operations and Systems Administrator
HREC Administrator Paul Smith will be joining the IT team as IT Operations and Systems Administrator to assist in supporting the businesses key functions including communication, data management, HREC submission and review and data analysis.
Both Molly and Paul have begun transitioning into their new roles and will continue to do so in the New Year.
Team Leaders
Joining Sally Sims, HREC Administrator Margaret Jelbart was successful in obtaining the position of Team Leader. Margaret commenced the role last month and brings all her previous research and governance experience, as well as a great knowledge of Bellberry processes to the role. Sheree Brozyna has also joined the Team Leader trio. Sheree comes to Bellberry having worked for a number of years as a forensic scientist. Her research, quality and analytics experience will be a great asset to the team bringing a valuable diversity of experience.
Quality Officer
We are delighted to announce that HREC Administrator Kate Fulton has recently been appointed as our new Quality Officer. After external advertising, Kate was the successful candidate amongst a strong field of applicants. Kate will be joining the Quality team early in the New Year.
Many congratulations to everyone in their new roles!
Due to the recent addition of Early Phase Clinical Trial (EPCT) reviews for NSW public health sites, organic business growth and in preparation for future growth, Bellberry has recently advertised and recruited to a number of new roles including new HREC Officers. Bellberry is delighted to announce that four new HREC Officers have recently joined the team. Maria Calarco, Dianne Palani-Stahl, Katie Trenorden and Mollie Van Rhoda all joined us in October. They come with a richness of experience including, Research, Medical Reception, HREC Administration and Recruitment. They have already become a great part of our wonderful Admin team and will be allocated their own Committee’s in due course.
Due to several internal staff changes as a result of newly created roles (further details to follow), Bellberry now has further vacancies for HREC Officers. Please visit the SEEK website for further information if you or anyone you know may be interested in this role. Closing date for applications is Fri 6 December.
For application details please visit SEEK
Two of five of our 2019 projects are now in the launch phase or complete: Project 1: Consumer Involvement and Engagement The Toolkit was launched at the ACTA International Conference on 4-October!! The Toolkit is a joint initiative between Australian Clinical Trials Alliance (ACTA) and Clinical Trials: Quality & Impact (CT:IQ) providing practical advice for researchers and research organisations wishing to conduct patient-centred clinical trials. Through the use of an interactive map, the Toolkit provides guidance and tools to help plan, deliver, evaluate and report consumer and community involvement and engagement activities. The Toolkit’s focus is clinical trials, however, much of the content is relevant to other types of health research. Development of a living repository accessible via an online platform provides a mechanism to share resources both locally and internationally in the future. https://involvementtoolkit.clinicaltrialsalliance.org.au/
Project 2: eConsent in Clinical Trials
‘Opportunities to enhance patient engagement’
This project was launched to CT:IQ members on the 24-Jun and was launched publicly at the AusBiotech International Conference on 31-Oct. This project, completed in partnership with Chrysalis Advisory, described the current use and adoption of eConsent, investigated barriers to the uptake of eConsent within the Australian clinical trial context and created actionable insights to support increased adoption of the technology.
Project 3: Early Phase Trials Best Practice
This project will identify, summarise and test recommendations for best practise conduct of early phase clinical trials. The team has just completed developing an excel based self-auditing checklist tool. Testing of the checklist tool with end-users is about to begin. The final checklist will be released to our members at the end of the year and publicly launched soon after.
Project 4: Clinical Trial Site Recruitment
This project will develop best practice guidelines for optimising clinical trial recruitment which are broadly applicable and translational at the site level. The project team has now finished drafting best practice guidelines and is currently looking at online tools to enable this information to be easily accessible to clinical trial site staff. The tool will be tested and released to our members at the end of the year and the associated website launched soon after publicly.
Project 5: Guidelines for Biomarker-directed therapies in personalised medicine: Tools for assessment.
The primary objective of this project is to guide policy makers and clinicians to what evidence is needed to make treatment recommendations for individual patients, especially linked to their Biomarker profiles. A systematic review of the current guidelines is underway and the first of two expert meetings was held on the 16th of November at the NHMRC CTC to refine the nature and scope of the problem.
CT:IQ Membership CT:IQ is the only initiative where government and clinical trial stakeholders can come together to undertake meaningful sector improvement initiatives. If you or your organisation is interested in improving the impact, quality or efficiency of the way clinical trials are conducted get in touch with CT:IQ’s Programme Director, Leanne Weekes, leanneweekes@ctiq.com.au and check out our website: https://ctiq.com.au
CT:IQ Programme Level Updates CT:IQ has presented five times at four conferences over the last quarter discussing CT:IQ sector improvement project progress; ARCS 2019, BioConnections 2019, the ACTA international Conference and AusBiotech 2019 in addition to participating in a second MTPConnect podcast and a Praxis Webinar.
25 – 29 November, Queenstown, NZ
‘Shared horizons: Optimising drug response to improve patient outcomes’
