Category: <span>Quality Activities</span>
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.
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!
Breakthroughs in prostate cancer screening and a ‘watch and wait’ treatment for collapsed lung share the Australian Clinical Trials Alliance 2021 Trial of the Year Award The Australian Clinical Trials Alliance (ACTA) is pleased to announce dual winners of their preeminent 2021 ACTA Trial of the Year Award. This event celebrates the vital role trials have in advancing clinical practice and saving or improving patients’ lives every year. The dual winners of the 2021 Trial of the Year Award are:
- ProPSMA Prostate-specific membrane antigen PET-CT in patients with high-risk prostate cancer before curative-intent surgery or radiotherapy (ProPSMA): a prospective, randomised, multicentre study.
- Pneumothorax study A randomised controlled trial of conservative versus interventional treatment for spontaneous pneumothorax.
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.
Join ACTA in honouring the remarkable Australians who advance our health system by designing, conducting, or participating in ground-breaking clinical trials and promote the importance of clinical trials and the expertise and complexity of the work involved.
This collaborative event will recognise the achievements of the research sector, with awards for the ACTA Trial of the Year, ACTA STInG Excellence in Trial Statistics, and the ACTA Consumer Involvement. The Award Ceremony will be preceded by the launch of the ‘Clinical Trials in Australia’ report and a panel session hosted by MTPConnect.
A networking reception will follow the Award Ceremony with drinks and canapes and the much-needed opportunity to connect with colleagues. Registration is essential and seats are limited.
2021 National Tribute and Award Ceremony Invitation
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.
It is now several months since Bellberry updated its procedures and we are pleased to report that there has been a significant drop in start-up times for additional sites.
The table beneath is a comparator of Jan/Mar 2020 to 2021. These months have been chosen as Jan/Mar may pre-date any COVID related issues sites may have, and in December 2020, the grace period ceased.
| Approval-Month | Count of Applications | Average of Bellberry Days |
| Jan-20 | 32 | 34 |
| Jan-21 | 39 | 13.05 |
| Feb-20 | 55 | 27.72 |
| Feb-21 | 54 | 10.38 |
| Mar-20 | 60 | 20 |
| Mar-21 | 72 | 10.45 |
Amendments are tracking at the same turnaround time in Bellberry days (3.8 days). The updated model’s difference is we now ensure all sites are listed on the one approval letter, as appropriate.
We appreciate the teething issues as sites, sponsors, and our administration tackle the changes together. If you have any questions or you would like to schedule a call with the quality team to discuss the practicality of the changes at your site, please email alisonbarr@bellberry.com.au.
Document Updates
We recently made some minor changes to some of our documents and guidance for researchers. A summary of the changes can be found here.
FAQs relating to the process changes rolled out in late 2020
[select-faq faq_id=’9326′]
[select-faq faq_id=’9329′]
[select-faq faq_id=’9332′]
[select-faq faq_id=’9333′]
[select-faq faq_id=’9334′]
[select-faq faq_id=’9335′]
[select-faq faq_id=’9336′]
[select-faq faq_id=’9337′]
[select-faq faq_id=’9338′]
[select-faq faq_id=’9339′]
[select-faq faq_id=’9340′]
[select-faq faq_id=’9341′]
This year ACTA will be recognising the outstanding achievements of its members at their National Tribute and Award Ceremony being held on International Clinical Trials Day (20 May 2021).
The ACTA Trial of the Year Award was established in 2016 to recognise and celebrate the outstanding achievements of its Members, who advance clinical practice and save or improve the lives of patients every year through investigator-driven clinical trials.
If you know of a ground-breaking clinical trial published in 2020 (electronically or in print) by a current ACTA Member, ACTA encourages you to nominate it for the ACTA 2021 Trial of the Year Award. Further information can be found on the ACTA website
The deadline for nominations is Sunday 14 March.
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)
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.
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!
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:
- Kylie Sproston, CEO Bellberry Ltd
- Ian Kerridge, PRAXIS Australia, University of Sydney
- Ian Burgess, CEO Medical Technology Association of Australia
- Liz Wilson, Director, Prime & Partner Site Management ANZ – IQVIA
- Tina Soulis, CEO Neuroscience Trials Australia
Other panellists:
- Megan Ford, Executive Director, Clinical Trials – Ingham Institute for Applied Medical Research and SWSLHD
- Peter Komocki, Manager, Industry & Regulatory Policy – Medicines Australia
- Caroline Duell, Director Communications and Events – MTP Connect
- Ben Laverty, Director, Site Management ANZ – IQVIA
- Wendy Keech, CEO Health Translation SA