eProtocol

NSW Early Phase Clinical Trial Framework

NSW Health Early Phase Clinical Trials

Under the NSW Health Early Phase Clinical Trial Scheme Bellberry HRECs have been appointed for the review of adult Early Phase Clinical Trial (EPCT) conducted at NSW or ACT Public Health Organisation sites (PHOs). Clinical Trials including phase 1 or early device feasibility are considered early phase, please refer to the NSW EPCT quick reference guide for further guidance.

In addition to Bellberry’s submission guidance, each application should include a NSW HREC Fee Form and address the following;

  • Planned numbers of participants to be recruitment at each site included in an application
  • A response to the following 2-part question: Please advise the committee of your plans for commencing and conducting this trial given the current public health considerations relating to the COVID-19 pandemic. Please also provide information regarding whether the potential enrolment of individuals will be impacted by their COVID-19 vaccination status (vaccinated or not), or whether participation in the study could impact subsequent COVID-19 vaccination.

For new applications on behalf of NSW or ACT PHOs, which have not previously undergone a Bellberry review, must be submitted via REGIS.

Multicentre EPCT applications, which will include a NSW or ACT PHO, can be reviewed by Bellberry under the NSW Early Phase Clinical Trials (EPCT) Framework with applications made via the following submission pathways:

  • Where the lead submission is from a NSW or ACT PHO, the lead application must be made via REGIS. Private institutions may be included as part of the REGIS application, either in the initial submission or via an amendment, or an application can be submitted directly to Bellberry via our eProtocol platform.
  • Where the lead submission is from a private institution, whose application has been received via eProtocol, an application for a NSW or ACT PHO may also be made either via REGIS or eProtocol. Please note that Bellberry requires an application from each site as part of a multicentre review made via eProtocol.

In either circumstance, a lead site can submit amendments or notifications to Bellberry on behalf of all approved sites during the lifecycle of the study.

 

Please note: each site is required to provide a site-specific annual Progress (Milestone) report. When applicable, such as when the lead site submission is via a platform other than eProtocol, the lead site can submit a collection of additional site Progress (Milestone) reports. Following site closeout, each site is required to provide a site-specific Final Report. Please refer to MAR G4 Progress and final reports and MAR F4.1.1 Progress report (eProtocol questions) for further information.

Non-commercially sponsored, investigator-initiated research applications submitted by NSW PHOs under the NSW EPCT framework may be eligible for a Bellberry fee reduction and NSW OHMR HREC fee subsidy support. Please contact the Bellberry EPCT team to discuss.

Under the EPCT Framework Senior Executives and/or Research Directors from NSW PHOs that are included as part of an application will be invited to attend the HREC meeting during the period the application will be considered by the Committee at a HREC meeting. The nominated Observer can nominate to attend in person or remotely.

For further information regarding applications please contact:

Jerneen Williams, Bellberry HREC EPCT Manager:
Contact: 08 8361 3222, Direct Line: 08 81224575
Email: JerneenWilliams@bellberry.com.au

Sally Gordon, Bellberry EPCT Project Officer:
Contact: 08 8361 3222
Email: SallyGordon@bellberry.com.au

Maria Calarco, Bellberry HREC EPCT Officer:
Contact: 08 8361 3222, Direct Line: 08 81224665
Email: MariaCalarco@bellberry.com.au

Ali Young, Bellberry HREC EPCT Officer:
Contact: 08 8361 3222, Direct Line: 08 81224582
Email: AlisonYoung@bellberry.com.au

For general enquiries please email: epct@bellberry.com.au