eProtocol

COVID-19 Updates

COVID-19 Update: 2 April 2020

Help on COVID-19 related amendments

Clinical trial and participant safety continue to be Bellberry’s top priority in light of COVID-19. The onset of the virus means you may need to submit amendments for your Bellberry approved clinical trial. The good news is that we’ve streamlined our processes to make it as easy as possible for your study to remain compliant.

To assist you, Bellberry will now accept a single submission of planned changes which may be applicable across several studies/sites. In addition, we can add the amendment to each relevant study in eProtocol for you, if you provide authorisation.

For more information about how we can help you with COVID-19 related amendments, please see COVID-19 submissions for approved research (MAR F1.1.8) and COVID-19 Submission application (MAR F1.1.9)


Summary of how we can help during COVID-19

  1. We have a dedicated COVID-19 response team, who can assist you with administration questions and ethics review pathways.  If you have any questions about your study and COVID-19 please email us at  covidsubmissions@bellberry.com.au
  2. We have established a roster of HREC reviewers to deal specifically with COVID-19 related amendments and to help us with the large workload currently seen.
  3. For Institutions and HRECs reprioritising workloads and redeploying their HREC and Research Office teams, Bellberry can provide contingency support on a cost-recovery basis only. Enquire at covidsubmissions@bellberry.com.au
  4. Bellberry can collect expressions of interest for the reallocation of public participants in multi-centre studies to private sites to allow for reprioritisation of hospital resources for the COVID-19 response.  This only applies in cases where study continuation is a safer and preferred option.  Contact covidsubmissions@bellberry.com.au to discuss.
  5. Bellberry is experienced in conducting emergency, fast-track reviews of pandemic-related studies. Our HRECS have more than 10 years of experience dealing with infectious disease and vaccine studies, such as seasonal flu and diagnostics. We have confirmed availability among our clinical experts to allow us to support COVID-19 related developments such as emergency reviews. We have had contact about a number of COVID-19 studies and will play our part in supporting fast-track development. If you need assistance, please contact Trina O’Donnell on 08 8361 3222.

Pandemic Planning tips

This is a time of rapid change, and evolving response. Bellberry has adapted our operations to support our research community with their COIVD-19 related clinical trial actions. Click here for a downloadable guide to common considerations.  Please contact us at covidsubmissions@bellberry.com.au if you have any questions.


NHMRC & CTPRG Guidance on changes in Clinical trials due to COVID-19

Please see the guidelines that have been issued by the NHMRC on changes in clinical trials due to COVID-19 as well as from the Clinical Trials Project Reference Group (CTPRG).


FAQ

  • We’re not in situation normal at present, and it is to be expected that every active study will need to make changes to continue; consider a temporary halt; or even discontinuation.
  • Bb HRECs will support you to consider and implement changes that protect the welfare of your participants.
  • Bellberry is also implementing changes to our normal administration processes to ensure that we can support the sector with the increased workload during this time.

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We’re working on defining routine changes that can be considered to be pre-approved, as per the CTPRG statement.  Check back often and we will have more information.

https://www1.health.gov.au/internet/main/publishing.nsf/Content/Clinical-Trials

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  • We recognise that everyone in the health system is under pressure at the moment, and we are looking for ways to make this easier for you.
  • Some amendments will be able to be notified as automatic amendments rather than amendments for approval.  Please contact covidsubmissions@bellberry.com.au for more information
  • For sites that mana a portfolio of studies, you can submit an amendment report to be associated with multiple studies at your site.
  • For sponsors, you can submit an amendment report to be applied to all relevant studies.
  • We’re aiming for single submissions for you, and the Bellberry COVID-19 response team will handle the rest.

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Patient and participant safety are an absolute priority. If you have to make an urgent change, please do so and notify the HREC without undue delay and within 72 hours of becoming aware of the change. All other significant safety issues that do not require the implementation of an urgent safety matter are to be reported within 15 calendar days of becoming aware.

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We recognise that the sector is enormously busy at present and expect that deadlines will come under pressure. Bellberry will be automatically extending ethics expiry dates to take into account the current situation.

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  • None of us are in situation normal right now.  We’re all supporting new ways of working, and we’ll support each other to make them work for the best.
  • If you’ve not used these systems before, consider now a good time to try.
  • Bellberry HRECs have supported all these methods and technologies in the past.  Talk to us for advice.

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COVID-19 Update 2 April 2020

COVID-19 Newsletter March 2020