Category: <span>Education and Resources</span>

Bellberry is proud to be the principal sponsor of the ASCEPT annual scientific meeting taking place virtually next week.

The ASM offers the opportunity to network with colleagues and other leading international and national scientists and academics at both social and scientific activities. A key feature of the ASM is the chance for early career researchers and research students to present their research findings in poster and oral presentations sessions. ASCEPT annual awards and prizes will also be presented at the ASM.

The program of plenary lectures, symposia and workshops, oral presentations and posters look to be scientifically stimulating. We look forward to seeing you online!

Bellberry is delighted to once again be a session sponsor at Bio Connections Australia. Bio Connections Australia explores drug development, early phase clinical trials, translational research and expediting Australia’s great science into commercialization. 2020 saw significant disruption to the drug development and clinical trials landscape in Australia and around the world and the research community are keen to reconnect, network, and learn. Bio Connections are excited to be moving back to in-person events but will continue to offer the option to attend the event virtually.

Jerneen Williams, Bellberry Early Phase Clinical Trial Manager will be attending this event and is also a panel member for the session titled ‘Delivering quality and efficiency in Australia’s clinical trials and addressing the resourcing challenge’. Please join Jerneen at this key event!

 

As most of our users have now formalised local governance processes for internal safety reporting, we have updated MAR G2 Safety reporting, to no longer require the submission of SUSARs for individual events at Bellberry sites.

To assist sites in understanding the updated requirements, if Bellberry’s administrative team receives documentation not outlined in MAR G2, a reference will be made to MAR G2, and the submission returned.

General advice to sites regarding submissions:

If your study is multi-centre, please ensure your submission considers the participants at all centres.

For example:
•   There is a halt in recruitment due to drug supply issues in Australia. The Sponsor has confirmed there will be no supply for three weeks.

Example wording for the site submission:
Our site is awaiting governance sign off and has not recruited any participants. We will not recruit until the halt is lifted.
Dr Peters (site AA) has recruited one participant, and they have enough study drug to last their participant for 6 weeks. If there is any update to the supply issue that puts this participant at risk, we will notify the HREC.

•    If the urgent safety measure includes a request to inform participants of a safety issue:

Example wording for the site submission:
Our site has four active participants. Prof Barnes (site AA) has two participants. All were phoned and told of the safety event and documented in their notes. No participant had any further queries on the matter.

If your study includes a caveat and you are attaching documentation in relation to the caveat, please ensure your submission details the purpose of your attachments.

For example:
•    The caveat on the initial approval letter requests the following “Please submit correspondence from the DSMB during Part A of the trial. Part B cannot proceed until the HREC has reviewed the DSMB letters and an updated PICF and protocol is approved”.

Example wording for the site submission:
The attached DSMB letters refer to the caveat from the HREC on the initial approval letters that all correspondence must be submitted during Part A of the trial. Once the safety letters are acknowledged, the site will submit an amendment for Part B with an updated PICF and Protocol for HREC consideration.

The ‘AER’ safety reporting pathway questions will be updated in eProtocol in due course. Until then sites are welcome to select option 2, ‘Summary report’ for all submissions, as the relevant information regarding dates of events should exist in the attachments.

Please take the time to reflect on the updated reporting requirements and how this will impact your local procedures.

If you have any queries regarding these changes please contact Bellberry at bellberry@bellberry.com.au

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

Click here for the full event program

Join Bellberry throughout AusBiotech 2021. The week includes:

Registration is open now!

Progress reporting realignment initiative

We have seen significant improvement with compliance since Bellberry began a significant progress reporting realignment initiative. The primary objectives of the project were to:

Progress and final reporting: guidance materials

Bellberry provides the following documents relating to progress and final reporting:

MAR G4 Progress and final reports

This guidance outlines researcher and sponsor obligations concerning progress and final reports as per clause 5.5.5 of the National Statement on Ethical Conduct in Human Research (2007 incorporating all updates).

BA G16 eProtocol navigation guide for researchers

This guidance provides a comprehensive list of questions asked via the eProtocol application forms. These forms have been updated to include what researchers should consider when preparing responses to progress and final report questions. Researchers may use these forms to prepare responses before submission to eProtocol.

Progress reporting key updates:

Each Principal Investigator is responsible for submitting an annual progress report relating to study activities at their site. Responsibility should only be delegated to site staff with appropriate understanding of site-based activities. Reporting opens within 30 days of the due date. Progress reports submitted outside of earlier than this time frame will be returned.

Often sites require submission of amendments and progress reports in a similar timeframe. eProtocol does not allow concurrent submissions of amendments and progress reports. To ensure that continuous ethical approval is maintained, where a progress report is due to be submitted (i.e. within 30 days of the due date) and an amendment is also required (e.g. protocol/IB update), the site must:

  1. Submit the progress report*.
  2. Phone or email bellberry@bellberry.com.au to request expedited review of the progress report
  3. Submit the amendment immediately post progress report acknowledgement.
  4. When applicable, please phone or email Bellberry to request urgent processing of progress reports preventing an amendment submission.

*When considering whether to attach documents to the progress report, please note that only documents directly relating to the progress report should be included. Any other documents must be submitted by the appropriate pathway (e.g. an amendment, safety, or serious breach form) as these reports are categorised and reviewed according to the extent and impact of any changes. Please see BA F1.1.1 Submission requirements checklist for further information.

If any discrepancies are identified when completing the progress report, the researcher should:

  1. Note the disparity in the appropriate question field in the progress report before the progress report is submitted.
  2. Provide the HREC with the relevant documentation through the appropriate pathway immediately post progress report acknowledgement (e.g. submission of an amendment, safety, or serious breach form).

Final reporting key updates:

If a Principal Investigator has finished the study at their site, and the progress report is due, and the closeout visit has not occurred, the site must submit a progress report. Once the closeout visit occurs, any outstanding correspondence identified as requiring submission is to occur by the appropriate channel (e.g. amendment, safety, serious breach) before submitting the final report to the HREC.

If you have any questions or queries regarding these updates, please contact the Quality Team at quality@bellberry.com.au.

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.

AusMedtech 2021: Reimagine and reconnect provides a week of virtual half-day sessions that represent Australia’s medtech industry; celebrate the successes and impacts the industry has made, and engage on the reimagined future of medtech.

Kylie Sproston, Bellberry CEO, will be part of a panel discussion being held on Tues 18 May titled ‘Lessons learnt: Clinical trials, ethics and governance, regulatory approvals and the new normal’

AusMedtech week will be delivered online

REGISTER NOW

The AAHRPP annual conference will take place from May 18 to May 20. Join Kylie Sproston, Bellberry CEO, and Dr. Amal Al Omari, Speakers Chief Scientific Officer King, Hussein Cancer Center at their session on May 20 entitled ‘International Research – Collaboration During Crisis’

REGISTER NOW!

Bellberry has updated the site-specific clauses document (BA F1.1.12) to include examples and a pre-submission checklist.

Please note the following:

Please see the updated form here.

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

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The Trustees of the Sylvia and Charles Viertel Charitable Foundation are pleased to announce two classes of research grants to be awarded in 2021 and commencing in 2022.

The Viertel Foundation was established to benefit organisations or institutions involved in medical research into diseases and the alleviation of the hardship of the aged and the sick. Bellberry began working in collaboration with the Viertel Foundation in 2016 to offer prestigious, high-value 5-year mid-career fellowships to the brightest research talent which increased the number of available Research Fellowships from two to three.

Senior Medical Research Fellowship & Bellberry-Viertel Fellowship

The Senior Medical Research Fellowship are intended to be amongst the most prestigious awards available to those who wish to continue a career in medical research in Australia. The Fellowship is an integral part of a scheme that is intended to provide both salary and project grant support for outstanding Australian medical researchers. One of the Fellowships available is the Bellberry-Viertel Senior Medical Research Fellowship. It has a five-year tenure at $250,000 p.a. for a researcher from any discipline in medical science to be awarded in 2021 and commencing in 2022.

Viertel Clinical Investigator awards

$85,000 is available for a clinical researcher who has recently completed their clinical and research training and is commencing their first substantive appointment (appointment of 5 years or more) clinical position or has been in such a post for no more than 36 months on 30 April. Up to five awards available this year.

The Foundation intends to award at least one (1) award to an eligible female candidate in both classes. Only Australian nationals or permanent residents are eligible for these awards.

The closing date for both awards is 30 April 2021.

Further information, including eligibility requirements and application forms, is available from The Viertel Charitable Foundation website, or email: charities@eqt.com.au.

AusBiotech invites you to its virtual showcase highlighting Australia’s clinical trial and medical innovation advantages, coinciding with the annual JP Morgan and Biotech Showcase week in January 2021. This virtual event will be hosted in Melbourne on Fri 15 Jan, 10-11.35am (AEDT).

Australia has been amongst the globe’s lesser COVID-19-impacted countries, providing the opportunity to start and continue clinical trials and medical research through the pandemic. Through careful management of the pandemic, clinical trials are not only giving Australian patients access to new therapies, vaccines and medical devices, but also giving the country a comparative advantage as a destination for clinical trials from around the globe.

Working in Australia offers a compelling opportunity for clinical trials, with robust regulation, access to established and proven pathways of obtaining high quality clinical data recognised by US and European regulators, and other global institutions.

Bellberry CEO Kylie Sproston will be speaking at this event. Click HERE TO REGISTER

The ACTA Summit 2020 will be a ‘virtual’ gathering of Australian and international experts to discuss the design and conduct of clinical trials, developments in clinical quality registries, embedding research into healthcare, new approaches to practice, and innovations in clinical trial governance and consumer engagement.

Bellberry is proud to be a gold sponsor for this event and Bellberry CEO Kylie Sproston will be speaking at a session on Weds 2 December entitled ‘Responses to COVID-19: the Broader Perspective’

The Clinical Trials 2020: National Tribute and Award Ceremony will also be presented during the Summit. We look forward to seeing you there!