The new normal: Pandemic planning tips
As we see restrictions beginning to lift across Australia, many sites are considering reopening or increasing their capacity. It is anticipated that if the curve remains flattened, the number of clinical trials being conducted will increase. Here are some key points to consider:
Who needs to be at the site? Many sites have successfully managed to transition a majority of their team to work remotely. How many people need to come back into the workplace? What is the limit of people that can be in the space whilst ensuring physical distancing takes place? How many participants is it safe to allow into a space at any one time? Can a family member (for instance) accompany a participant? Do you have full details of every person who enters the premises? What is the plan for suppliers and deliveries?
Are there separate physical spaces for instance for healthy volunteer participants and vulnerable participants? Are there separate teams working in the space? What processes are in place to ensure physical distancing takes place at all times? Is there adequate signage so people coming to the site understand the layout and procedures?
Is there the ability to scale up or scale down operations in the case of a local outbreak? Are there clear procedures in your SOP if someone who has been in the site tests positive to coronavirus?
Support for remote interactions with sponsors and study teams
Has clear communication been established with sponsors and study teams on processes and procedures within the site? Do you have the technology infrastructure to allow for up-to-date communication remotely with other parties? Can sponsors and study teams easily communicate with the site remotely?
The local environment
Are you monitoring what is happening locally with COVID-19? Are you in contact with local health authorities or accessing up-to-date data to understand the local situation? Have you clear lines of communication and a plan if there is a local outbreak of Coronavirus?
Click here for a downloadable guide to common considerations. Please contact us at firstname.lastname@example.org if you have any questions.
Submissions of new studies during the pandemic
Bellberry HRECs continue to operate during this time fully remotely. As we consider all new applications and amendments to research projects we will be asking researchers to comment on how the pandemic affects their research project and what considerations and actions they have put in place.
As we start to consider the end stages of the pandemic, Bellberry HRECs will still ask these questions. Sites should consider their practices for reopening, and those practices that may need to be ramped up and down to deal with localised outbreaks as they may occur through the recovery period. More information about planning for reopening can be found via the SafeWork site.
Clinical trial and participant safety will continue to be our priority as well as any potential additional impact of research on our health systems. In some instances, it may be appropriate that the study is deferred until a later date. For other studies, there could be no impact: for example, where a study is not planned to start until after the pandemic period has passed.
Concerns about the potential impact on health systems have reduced as the peak pandemic period has passed. In some cases where a temporary recruitment halt was applied over the peak period, that may now be withdrawn.
Importantly there will be some research where it is vital that it continues during this time, especially those related to the pandemic. We aim to ameliorate the impact that this pandemic has on your critical research studies to keep them on track.
Bellberry will apply these considerations on a study by study basis as part of our review. A list of planning considerations can be found here.
Sites are encouraged to reach out to the HREC for support and assistance.
Summary of how we can help during COVID-19
- 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 email@example.com
- 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.
- 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 firstname.lastname@example.org
- 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 email@example.com to discuss.
- 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.
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).
- NHMRC – https://www.nhmrc.gov.au/research-policy/COVID-19-impacts
- CTPRG – https://www1.health.gov.au/internet/main/publishing.nsf/Content/Clinical-Trials
The batch pathway can be used for anything that applies across multiple sites/studies. While it was originally set up to help the sector for submission of COVID-19 related bulk notifications/amendments, its scope has been expanded to help users more broadly.
Protocol deviations and violations are determined by the PI and do not need to be reported to the HREC. Only safety events/serious breaches are required to be reported. Refer to MAR G3 Protocol violations and serious breaches for more information.
Bellberry acknowledges that from time to time, submission information may be requested by other parties, such as the Sponsor. In these instances, please submit via eProtocol or the batch pathway.
Please register for an eProtocol account here, complete the BA F2.1.3 Nominated Contact Authorisation form and send it back to firstname.lastname@example.org to complete the registration. Please note that the first section in the form is to be completed with the Sponsor’s details and the second section is to be completed by the PI with their details.
If you previously submitted a notification to Bellberry to pause trial/s, then, submit a further notification to resume trial activities. On the other hand, if the protocol was amended to pause trial/s, then, submit another amendment for review to resume the trial/s.
I have submitted an amendment through eProtocol for a study. I now want to submit another amendment but eProtocol will not generate another form. What do I do?
You can only submit one amendment/submission at a time in eProtocol restricting the ability to submit additional ones. In this scenario, please submit the new amendment/submission to email@example.com.
Sponsor monitoring arrangements, or changes to this, are outside of the HREC’s scope and does not require Bellberry approval.
Most studies have been impacted by COVID-19 and will be delayed as a result. Please submit a progress report and request for an ethics extension.
Clinical trial activities have been affected differently in Australia depending on local circumstances. Regardless, trials are getting back to normal or getting back to full speed across the country at present. In all cases, resumption of clinical trial activities at sites must be assessed on an individual basis taking into account your local context, the nature of your study and the needs of your Participant and Patient groups. Following relevant health guidelines, assess whether your Site is ready to resume clinical trial activities. We encourage you to reach out and discuss your situation by emailing firstname.lastname@example.org.
- 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 has also implemented changes to our normal administration processes to ensure that we can support the sector with the increased workload during this time.
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.
- 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 email@example.com 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.
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.
We’ve never had ethics approval for remote visits, e-consent, electronics signatures and remote monitoring. Is this ok?
- 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.
Yes we can. Bellberry has experience 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. undertaking expedited reviews and has established systems and processes to allow these to happen. We have confirmed availability among our clinical experts to allow us to support COVID-19 related studies such as treatments, diagnostics or test kits.
It depends on the quality and the completeness of the application we receive. Our aim is to meet and review an expedited COVID study submission within 48 hours of receipt. We encourage you to reach out and discuss a potential submission, please contact Trina O’Donnell on 08 8361 3222 or email firstname.lastname@example.org
There is no extra charge for a pandemic related emergency review. We offer this service as part of our contribution to the race to provide better COVID-19 health outcomes. Please refer to our fees and charges page to understand our fee structure https://bellberry.com.au/im-a-researcher/our-fees/
For many Bellberry approved clinical trials, notifications or amendments are required as a result of the altered environment due to COVID-19. We have streamlined our processes to make the process as straightforward as possible for your studies to remain compliant.
To assist you, Bellberry has developed a batch submission pathway to allow a single submission of notifications or amendments applicable across multiple studies and/or multiple sites for consideration by Bellberry’s HRECs. Upon your authorisation, we are also able to add the notification/amendment to each relevant application in eProtocol. Following this, our standard procedure of review and decision outcome will take place.
We appreciate that (like Bellberry) many people in our sector are working remotely and are unable to provide or obtain handwritten signatures. This provides a great opportunity to transition to electronic signatures (e-signatures). We accept many e-signature platforms, as long as the signature can be electronically verified. Two of the most common e-signature platforms that offer electronic verification are Adobe and DocuSign.