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. To kick off in 2020, please find below an update of the significant changes that will impact research sites and sponsors. These changes will be rolling out in the coming days, weeks and months.
If you have any suggestions for future quality improvements initiatives, please email quality@bellberry.com.au.
Sponsor access to eProtocol
Sponsors and CROs wishing to access studies in eProtocol can now liaise with the site Principal Investigator to obtain access.
- Sponsors can assist with all parts of the application but cannot press ‘submit’. This remains the responsibility of the Principal Investigator.
- Principal Investigators retain control of all persons that they wish to allow access to.
Progress reports
Moving to a one-year term of approval cycle from March 2020.
- Studies approved before March 2020 will remain with current terms and conditions.
- A protocol violation report must be submitted for any progress report that is submitted after midnight on the date it is due.
- All sites urged to review their open studies to ensure their progress reporting is up to date.
Application form
The application form has had some minor question changes.
- Sites need to be mindful of these changes when applying and read all questions carefully.
- Declaration of the Principal Investigator has changed.
Document changes
There are several changes to Bellberry documentation. Many documents that you previously knew as policies are now sitting in an updated structure of Guidance and Resources. Click here for a table of all documents both old and new. This list is not exhaustive; it contains only references to the former policies.
Site monitoring
From 2020, site monitoring will occur in two ways – face to face and via desktop auditing.
- Sites will be given a template to complete for desktop audits.
Institutional responsibilities
By the end of the first quarter of 2020, there will be changes to some documents that Bellberry requests, including site-specific documents.
- We are currently working with pilot sites & sponsors to test the new process and forms.
- Sites are encouraged to spend the coming months preparing for how they will manage their internal document flow, version control and authorisation process.
- These examples relate purely to what documentation is uploaded, and each site is still responsible for creating their own ‘site application’ in the system.