Category: <span>Bellberry Community</span>
Join experts from Austrade, Baker McKenzie, Bellberry and IQVIA in a discussion on conducting clinical trials in Australia. This one hour webinar will explore:
- the benefits of conducting clinical trials in Australia for US companies
- the steps in the clinical trial process
- due diligence issues to consider
- how to apply for an Australian R&D tax incentive.
There will also be an opportunity for questions. Bellberry CEO Kylie Sproston will be part of this discussion.
Click here to register!
Congratulations to Bellberry CEO Kylie Sproston on being a winner of the 2021 ARCS MTP Sector Awards. Kylie was announced as the Innovation award winner at the ARCS 2021 awards dinner in Sydney last night. Other recipients were NSW Health, Pathology, as innovation award winner and Co-Directors Nick Ward and Johanna Hann from PharmatoMarket winners of the Leadership award.
Kylie was honoured to receive the award and said “In accepting this award, I’d like to acknowledge my incredible team at Bellberry: staff, HREC member community and our supportive Board. We’re forever asking ourselves how we can better deliver on our objectives: to improve the welfare of human research participants and improve the quality, efficiency and effectiveness of research.
Delivering on those objectives is only possible with the teamwork that happens every day in the clinical trials environment: research site staff, investigators, CROs and Sponsors coming together to deliver health and medical research. The last word as always should go to the communities in which we operate and our participants, without whom none of this is possible”
The Bellberry team celebrated International Clinical Trials day with a morning tea hosted by our EPCT team.
Jerneen Williams (HREC EPCT Manager) provided information on the background to International Clinical Trials Day, gave an update on the EPCT team and showed two video clips showcasing clinical trials from two different perspectives – one from a clinical research organisation (https://www.rarecancers.org.au/page/82/clinical-trials) and one from a trial participant (https://vimeo.com/272688909).
Photos from today’s event:
Bellberry also published its May Newsletter today with includes articles about International Clinical Trials day, ACTA’s National Tribute and Awards ceremony being held tonight, our Clinical Trial Activity Report for 2020 and much more! Please take some time out to read.
Bellberry is the largest independent reviewer of CTN trials in Australia. This year on Clinical Trials Day, we’re pleased to share a summary report which describes research activity overseen by Bellberry HRECs through 2020.
This activity report represents a significant proportion of the Australia wide CTN trial activity across the development lifecycle. It demonstrates capability and capacity in a broad range of research areas. The report also captures the originating funding location for inward investment in Sponsored clinical trials, again demonstrating Australia’s active participation in the global development process.
Bellberry Clinical Trial Activity Report 2020 (169 downloads )
Bellberry has updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist.
Please note the following:
- As a minimum, the HREC requires sites to outline their changes to the Master Main PICF.
- A review of the clause documents has found that most sites only make changes to the Master Main PICF. Therefore, to improve efficiency, the HREC will no longer return the site-specific clauses template if the site has overlooked listing supplementary PICFs (e.g. pregnant partner, optional biomarker PICFs).
- As per the terms and conditions of HREC approval, the site must submit an amendment if any ethical changes to content are required.
Please see the updated form here.
On Tuesday 13th 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 2020 academic year was Natasha Vincent, a second-year Bachelor of Biomedical Science student with the highest achievement in the unit. Bellberry passes their congratulations on to Natasha.
The Bellberry team recently returned to the office after another period of rostered working from home. It’s been a year since we first experienced working from home and during that time the team have adapted well to the challenges that the COVID situation has presented.
We have amended several of our internal processes and ways of working in order to improve the support given to sites in light of the COVID pandemic. We have introduced mechanisms to help fast-track COVID related submissions including a dedicated COVID-19 response team, batch submission pathway and fast track HREC meetings, especially for COVID studies.
We provide 3 weekly HREC meetings and all our meetings continue to be held remotely.
If you need support with your submission or have any other queries, please contact the Bellberry team at bellberry@bellberry.com.au
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. In November 2020, several important changes to the Bellberry submission process came into effect.
The transition period for these changes has now ended. From 1 Jan any documents submitted that do not comply with these changes will be returned with guidance on how to proceed. If you have any queries regarding these changes, please contact the Bellberry office at bellberry@bellberry.com.au
Key Changes
Master and site specific PICF and other participant facing documents
New applications: The first submitting/lead site must consult BA F1.1.17 PICF submission pathways to determine how the master study documentation will be submitted. There are now three submission pathways:
- Option 1 for single centre submission;
- Option 2 is a flexible submission pathway (which is the same as currently in place);
- Option 3 for where the initial submitting/lead site takes submission responsibility.
A question has been added to the application form asking the Principal Investigator to confirm which PICF pathway has been chosen for the submission. Only one pathway may be selected per study for review by a Bellberry HREC. Each additional site will need to align with the study’s nominated pathway, chosen by the first submitting/lead site.
Sites are no longer required to submit tracked and clean site-specific PICFs and other site-specific participant facing documentation to Bellberry. This change allows sites with research governance offices (or other formal institutional arrangements for reviewing site-specific documentation) to go ahead without the need for further HREC review. Sites that do not have a formal institutional arrangement will be responsible for developing a local procedure for document management.
The PICF submission pathway will determine what documentation is required from each site. Major site-based changes (e.g. radiation, pregnancy, reimbursement) to the PICF/participant facing documentation may be written in the master document as placeholders, or by the completion of BA F1.1.12 Site-specific clauses. The content will be reviewed by the HREC in the format determined by the PICF pathway. Minor administrative changes will be the responsibility of the site and do not need to be submitted to Bellberry. These include adding the site name, Principal Investigator details, amending footers, formatting, and other typographical errors.
For current/ongoing studies: Most studies will already be consistent with one of the PICF pathways. If a site has submitted a site-specific PICF/document to Bellberry, the HREC will have already approved the site-specific content and listed it on an approval letter. If the master document is updated, the site can continue to imbed previously approved clauses into the new site-specific PICF/document without the need for further HREC review. If the site wishes to change a clause, the site must submit an amendment using the BA F1.1.12 Site-specific clauses template.
Initial applications and reviews
Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study documents. Additional sites will not need to submit any study documentation that has been submitted by the first submitting/lead site, irrespective of when the additional site joins. However, additional sites are responsible for submitting documents that have not been submitted by the first submitting/lead site (e.g. documents pertaining to the additional site: CV, social media plan, advertising, etc.). Please refer to BA F1.1.1 Submission requirements for further information.
Additional site submissions will be considered by the Chair/reviewers as the first submitting/lead site enters cycle comments, post-HREC review. When the first submitting/ lead site is ready for approval, any additional sites that have fulfilled the HREC’s requirements will be included on the first submitting/lead site approval letter.
Additional sites approved post initial approval
When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.
Please refer to BA F1.1.7 HREC process flowchart for further information.
Amendments and safety reporting
If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master PICF or investigator brochure, DSUR, ASR), the submission will be reviewed on behalf of all Bellberry approved sites. In the event the submission does not apply to all of these sites, the submitting site must provide an explanation. Please refer to MAR F1.1.3 amendment pathways flowchart for further information.
Serious breaches
Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to reflect the NHRMC’s serious breach questions. Sites may complete these questions, or upload MAR F3.1.1 Serious breaches report form – sponsor or MAR F3.1.2 Serious breaches report form – third party, as applicable.
Please note, the acknowledgement letter will code the item as ‘PVR’; this is system-generated and cannot be altered.
Progress reports
Minor changes have been made to the progress report form to incorporate the need for submissions to include an update on any conflict of interest changes for the research team, and for a comment on compliance with any: governance approvals; submission of amendments; safety reporting; annual progress reporting; notification to the HREC of regulatory audits; appropriate use of data; caveats placed on the approval; statutory and licensing obligations. See MAR F4.1.1 Progress reports (eProtocol questions).
Version control and document naming conventions
For clarity, Bellberry requests files to contain the title, version and date of the document. Please refer to BA G12 Version control and document naming conventions for further information.
HREC Indemnities
Bellberry accepts both electronic and hard copy HREC Only indemnities. If an indemnity is to be sent via an electronic platform such as DocuSign or AdobeSign, please do not complete any fields for the Bellberry signatory.
Please send any electronic HREC Only Indemnities to bellberry@bellberry.com.au. If your processes require it to be sent to an individual, please also copy to bellberry@bellberry.com.au.
Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities
Site monitoring and desktop audits
Changes to the administration and approval processes will be monitored through the Bellberry site monitoring programme, in order to assess the compliance with the outlined process changes. A review of the implementation of these changes will be undertaken to ensure overall suitability.
Bellberry routinely monitors sites and studies. Sites selected for monitoring may be for cause or chosen at random. In 2020, Bellberry has added desktop auditing to the annual monitoring calendar. (Through 2020 it is anticipated that all monitoring will be undertaken via remote methods, with a return to physical site monitoring when safe to do so.)
From 2021, the changes to administration of additional sites will form part of the monitoring agenda. If your site or study is selected for monitoring (either by desktop or site visit methods), the Bellberry quality team will email all relevant forms for completion to the Principal Investigator and nominated contacts.
Submission requirements
As a reminder, earlier this year, Bellberry removed the requirement to submit the following documents for which the institution is responsible:
- Insurance certificates
- Standard indemnities
- Site approval forms*
- Protocol signature pages
- Professional indemnities
These are still required to be in place, and available at the site.
*Site approval forms, in this context, refer to the procedure of form put in place by the Institution or Organisation conducting the research. The Bellberry site approval form has been retired.
A list of submission requirements is available under Bellberry Applications BA F1.1.1 Submission requirements checklist.
Sponsor submissions
Sponsor representatives are able to help build the applications in eProtocol. See registration requirements under BA G1 Submission requirements and responsibilities
Summary of Changes document (including all related documentation and staff contacts)
We hope you all had a safe and happy Christmas break and look forward to working with you again in a hopefully much calmer 2021!
As always if you have any queries please contact the Bellberry team at bellberry@bellberry.com.au
Bellberry has signed up to take part in the BR/GHT walking challenge this December as a Team “Bellberry Allstars”, raising funds for SAHMRI’s lifesaving medical research.
SAHMRI (South Australian Health and Medical Research Institute) is conducting inspired research that leads to better health outcomes for all. The Institute is home to more than 650 of the brightest researchers from across Australia and the world, working together to find solutions to the biggest health challenges of our time – cancer, stroke, Aboriginal health, diabetes, heart disease, premature birth, dementia, spinal cord injury, mental health and wellbeing and more, including COVID-19.
The challenge takes place from 3 – 12 December and the BB Allstars will be walking hard to achieve their goals!
Click here to view the Bellberry fundraising page.
Further information about the challenge can be found here.
To our valued Bellberry community:
In line with South Australian 6-day circuit breaker restrictions introduced today, Bellberry has closed our Adelaide office. At this stage, the closure is planned for 19th-24th November and will be reviewed as more information becomes available. We will be working remotely for the time being.
Bellberry HRECs perform an important role: in terms of review of new research, the oversight of ongoing research and the provision of a participant contact pathway. We are committed to ensuring that our work continues in a safe and seamless manner regardless of what happens with COVID this year.
The Bellberry team initially trialled remote working practices in February and moved to fully remote services for the first time in March. Since then, our office occupation rate has flexed up and down according to the COVID environment in South Australia. We see today’s changes as simply the latest stage of this journey.
For our research users who access our services from across the country: it is business as usual for the Bb team (even if our desk locations are not). Our Bb pets are delighted to have us all at home again!
We support our public health colleagues in their work to control this outbreak and thank them for all their efforts.
Kylie Sproston – Chief Executive Officer – Bellberry Ltd
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.
As of 2 November 2020, several important changes to the Bellberry submission process will come into effect. Bellberry will assist sites in transitioning to the new approach and will continue to accept documents from sites that are creating procedural changes. If your study is currently in preparation, the Bellberry team can assist to guide you through the changes.
There will be a transition period which will end on 31 December 2020. Documents submitted after this date that do not comply with these changes will be returned.
Key Changes
Master and site specific PICF and other participant facing documents
New applications: The first submitting/lead site must consult BA F1.1.17 PICF submission pathways to determine how the master study documentation will be submitted. There are now three submission pathways:
- Option 1 for single centre submission;
- Option 2 is a flexible submission pathway (which is the same as currently in place);
- Option 3 for where the initial submitting/lead site takes submission responsibility.
A question has been added to the application form asking the Principal Investigator to confirm which PICF pathway has been chosen for the submission. Only one pathway may be selected per study for review by a Bellberry HREC. Each additional site will need to align with the study’s nominated pathway, chosen by the first submitting/lead site.
Sites are no longer required to submit tracked and clean site-specific PICFs and other site-specific participant facing documentation to Bellberry. This change allows sites with research governance offices (or other formal institutional arrangements for reviewing site-specific documentation) to go ahead without the need for further HREC review. Sites that do not have a formal institutional arrangement will be responsible for developing a local procedure for document management.
The PICF submission pathway will determine what documentation is required from each site. Major site-based changes (e.g. radiation, pregnancy, reimbursement) to the PICF/participant facing documentation may be written in the master document as placeholders, or by the completion of BA F1.1.12 Site-specific clauses. The content will be reviewed by the HREC in the format determined by the PICF pathway. Minor administrative changes will be the responsibility of the site and do not need to be submitted to Bellberry. These include adding the site name, Principal Investigator details, amending footers, formatting, and other typographical errors.
For current/ongoing studies: Most studies will already be consistent with one of the PICF pathways. If a site has submitted a site-specific PICF/document to Bellberry, the HREC will have already approved the site-specific content and listed it on an approval letter. If the master document is updated, the site can continue to imbed previously approved clauses into the new site-specific PICF/document without the need for further HREC review. If the site wishes to change a clause, the site must submit an amendment using the BA F1.1.12 Site-specific clauses template.
Initial applications and reviews
Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study documents. Additional sites will not need to submit any study documentation that has been submitted by the first submitting/lead site, irrespective of when the additional site joins. However, additional sites are responsible for submitting documents that have not been submitted by the first submitting/lead site (e.g. documents pertaining to the additional site: CV, social media plan, advertising, etc.). Please refer to BA F1.1.1 Submission requirements for further information.
Additional site submissions will be considered by the Chair/reviewers as the first submitting/lead site enters cycle comments, post-HREC review. When the first submitting/ lead site is ready for approval, any additional sites that have fulfilled the HREC’s requirements will be included on the first submitting/lead site approval letter.
Additional sites approved post initial approval
When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.
Please refer to BA F1.1.7 HREC process flowchart for further information.
Amendments and safety reporting
If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master PICF or investigator brochure, DSUR, ASR), the submission will be reviewed on behalf of all Bellberry approved sites. In the event the submission does not apply to all of these sites, the submitting site must provide an explanation. Please refer to MAR F1.1.3 amendment pathways flowchart for further information.
Serious breaches
Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to reflect the NHRMC’s serious breach questions. Sites may complete these questions, or upload MAR F3.1.1 Serious breaches report form – sponsor or MAR F3.1.2 Serious breaches report form – third party, as applicable.
Please note, the acknowledgement letter will code the item as ‘PVR’; this is system-generated and cannot be altered.
Progress reports
Minor changes have been made to the progress report form to incorporate the need for submissions to include an update on any conflict of interest changes for the research team, and for a comment on compliance with any: governance approvals; submission of amendments; safety reporting; annual progress reporting; notification to the HREC of regulatory audits; appropriate use of data; caveats placed on the approval; statutory and licensing obligations. See MAR F4.1.1 Progress reports (eProtocol questions).
Version control and document naming conventions
For clarity, Bellberry requests files to contain the title, version and date of the document. Please refer to BA G12 Version control and document naming conventions for further information.
HREC Indemnities
Bellberry accepts both electronic and hard copy HREC Only indemnities. If an indemnity is to be sent via an electronic platform such as DocuSign or AdobeSign, please do not complete any fields for the Bellberry signatory.
Please send any electronic HREC Only Indemnities to bellberry@bellberry.com.au. If your processes require it to be sent to an individual, please also copy to bellberry@bellberry.com.au.
Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities
Site monitoring and desktop audits
Changes to the administration and approval processes will be monitored through the Bellberry site monitoring programme, in order to assess the compliance with the outlined process changes. A review of the implementation of these changes will be undertaken to ensure overall suitability.
Bellberry routinely monitors sites and studies. Sites selected for monitoring may be for cause or chosen at random. In 2020, Bellberry has added desktop auditing to the annual monitoring calendar. (Through 2020 it is anticipated that all monitoring will be undertaken via remote methods, with a return to physical site monitoring when safe to do so.)
From 2021, the changes to administration of additional sites will form part of the monitoring agenda. If your site or study is selected for monitoring (either by desktop or site visit methods), the Bellberry quality team will email all relevant forms for completion to the Principal Investigator and nominated contacts.
Submission requirements
As a reminder, earlier this year, Bellberry removed the requirement to submit the following documents for which the institution is responsible:
- Insurance certificates
- Standard indemnities
- Site approval forms*
- Protocol signature pages
- Professional indemnities
These are still required to be in place, and available at the site.
*Site approval forms, in this context, refer to the procedure of form put in place by the Institution or Organisation conducting the research. The Bellberry site approval form has been retired.
A list of submission requirements is available under Bellberry Applications BA F1.1.1 Submission requirements checklist.
Sponsor submissions
Sponsor representatives are able to help build the applications in eProtocol. See registration requirements under BA G1 Submission requirements and responsibilities
Summary of Changes document (including all related documentation and staff contacts)
AusBiotech + Invest 2020 – Australia’s largest life science conference is back and will be delivered online live 28 – 30 October and on-demand. Join Bellberry online at AusBiotech next week!
The 2020 Australian Academy of Health and Medical Sciences (AAHMS) Annual Scientific Meeting will be held online this year enabling it to be open to both the research community and the wider public. The meeting is spread over two days and aims to explore the latest developments for precision medicine and emerging science around prevention and control, including in relation to the COVID-19 pandemic.
Day 1 ‘Progressing precision medicine’ will review the current status of precision medicine in Australia and ask how we can better translate science into reality.
Day 2 ‘Progressing public health, prevention and control’ will ask how Australia can best progress public health, prevention and control over the coming months, years and beyond.
Professor Ingrid Scheffer AO FRS FAA PresAHMS, President, Australian Academy of Health and Medical Sciences says, “Our annual meeting feels especially apposite this year, with health and medical sciences having such a prominent role in society during 2020. We will take the opportunity to reflect on the pandemic so far and look ahead to what might come next. We will also consider broader topics for the health of the public, including the current status of precision medicine in Australia and how we can accelerate the benefits of this promising area. Bellberry has been a great supporter of our Annual Meeting and we look forward to partnering with them again this year to tackle these important topics.”
The event is hosted by Professor Ingrid Scheffer and Professor Tony Cunningham AO FAHMS and includes a plethora of renowned speakers across the two days. AAHMS CEO Catherine Luckin states this year’s event will place a real emphasis on panel discussion with an online Q&A participation forum to enable participants to become involved.
As a long term supporter of AAHMS, Bellberry is proud to sponsor this prestigious event once again. As a Not For Profit organisation, Bellberry reinvests proceeds into the medical research community in order to further the dual objectives of improving the welfare of research participants and supporting the quality, efficiency and effectiveness of research.