Category: <span>HREC News</span>

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.

See Guidance and Resources

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.

As we entered 2020 Bellberry celebrated the New Year by reaching our 50th submission for NSW Health Early Phase Clinical Trials.

Bellberry HRECs were appointed by NSW Health for the review of adult Early Phase Clinical Trial (EPCT) applications early in 2019. From April 2019, all EPCT HREC trials conducted at an NSW Public Health Organisation (PHO) site had to be reviewed and approved by an appointed NSW Health EPCT HREC.

Many congratulations to our EPCT team for all their hard work in achieving this milestone!

For further information regarding applications or for submission help please visit the EPCT section of the Bellberry website or contact the Bellberry HREC EPCT Manager Jerneen Williams

For application details please visit SEEK

Last month CanTeen became the latest organisation to join the CT:IQ Steering Committee. Bringing an important perspective, CanTeen help young people cope with cancer in their family and provide specialist youth-specific treatment teams and have young people affected by cancer guiding the organisation at every level. CanTeen are one of the many organisations that have demonstrated their support of the CT:IQ initiative by joining the Steering Committee. Others include the Icon Cancer Foundation, Novartis, SPHERE, Cancer Trials Australia, Neuroscience Trials Australia, Linear and CMAX.

In June Medicines Australia also announced that they were joining the executive committee. For further information about the CT:IQ initiative please visit their website at https://ctiq.com.au or if you are interested in joining please visit https://ctiq.com.au/contact-us

We are pleased to announce that NHMRC funding for the National Scientific Committee’s (NSC) pilot project has been extended for a further 12 months.

The NSC’s were launched by the NHMRC in January and provide scientific review for the areas of Complex Genetic Research and Medical Devices. Based on the queries received from the initial pilot period, the review areas have also now been extended to include early phase clinical trials. The Committee’s, hosted by Bellberry, provide advice to HRECs, sponsors and researchers on the scientific merit and integrity of a research protocol.

Three applications have been submitted so far with two of these being reviewed at the inaugural NSC meeting held in June. The NHMRC funding extension will enable the project to continue until June 2018.

If you are interested in submitting a proposal to the NSC or for further information about the Committee’s please visit the NSC website or contact the NSC administrator at nsc@bellberry.com.au

Click here to read our exciting March newsletter with details of our new Committee’s, donation information, NHMRC adverse events reporting changes, staff changes and much more!

This month we were delighted to welcome back Lauren Griswood (nee Guscott) to the Bellberry team. Lauren previously worked at Bellberry as a Committee secretary but has returned in a new role as administrator for the new NHMRC funded National Scientific Committee’s (NSC) that are being hosted by Bellberry.

The NSC’s were launched by the NHMRC in January and provide scientific review for the areas of Complex Genetic Research and Medical Devices. The Committee’s will provide advice to HRECs, sponsors and researchers on the scientific merit and integrity of a research protocol. Lauren was involved in the setup of the Committee’s and will be administrating then going forward.

Please feel free to contact Lauren for further information about the Committee’s and how to submit a proposal at nsc@bellberry.com.au

Further information can also be found at the NSC website

From 1 July 2015 the Clinical Trials Notification (CTN) Scheme transitioned from a paper based form to an online format. The paper-based notification form is now no longer available as there are some differences in the required information for the online form.

As a reminder any paper based forms the TGA receive after 1st July 2015 will need to be submitted online via the TGA Business Services website

Bellberry have prepared a Guidance document for Bellberry applications. This is available on the Investigators pages under Policies, SOPs, Guidance. Please contact us if you have any queries.

Bellberry@bellberry.com.au

‘International Conference grapples with ethics’

Bellberry was in the news again recently after the hugely successful Crossover Conference, hosted by Bellberry in October, ABC News wrote a full article on the event. To listen to ‘The World Today – Patients demand more rights in clinical cancer trials 24/10/2014’ article and hear E/Prof Lloyd Sanson and Chris Henshaw speaking about the Congress please click here

Bellberry achieved a significant milestone in July with the first interstate HREC meeting being successfully conducted in Queensland. Committee E, registered with the NHMRC in May, held its inaugural HREC meeting in Toowong on Wednesday 9th July with fantastic input from the six locally attending members and two members joining via teleconference from South Australia.

Our thanks to Life Sciences Queensland for the use of their facilities and for extending a very warm welcome.

Bellberry is delighted to announce that its 5th Human Research Ethics Committee has been registered, ahead of an inaugural meeting in July 2014.

In the preparation phase ahead of the formal launch, the Bellberry team has been busy behind the scenes with the recruitment and selection process. All new HREC members are being supported with a training and development programme ahead of launch. This programme includes:
• induction training in Bellberry processes and policies,
• technical support in the virtual ethics collaboration environment.
• observation activities gaining experience in ethics review in existing committees.
• mentor support.

The 5th committee adds further capacity to the Bellberry ethics review process. With Bellberry holding at least one HREC meeting every week, we are able to provide researchers with a 2-week lead time from submission to review