Please find below our most commonly asked questions from the past couple of months. As always if you have any COVID-19 related queries please contact firstname.lastname@example.org. All other queries should be directed to email@example.com. We’re here to help.
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 organisational verification of personnel 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.