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 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
    • Estimated numbers of participants to be recruitment at each site included in an application (This can be noted in HREA Q1.2 or on a cover letter)

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

Multicentre EPCT applications, which will include a NSW 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 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, application(s) for NSW PHO’s can be made via eProtocol or REGIS. Please note the following guidance for submissions made via;
    • eProtocol, Bellberry requires an application from each site as part of a multicentre review.
    • REGIS, the HREA need only include a minimum data set and may reference information contained within the Protocol, IB or lead site application. Site specific information such as the site, investigator and study staff information, participant recruitment and consent practices, participant populations, and data access and management considerations should be detailed within the HREA. Please also note the guidance to the following HREA registration and application questions:

Project Registration A1. Has the project ever received ethics approval or has an ethics application from ever been submitted to an NHMRC registered HREC, for the project?

Answer NO so that a HREA application is generated.

HREA Q1.13 Has this research project had prior ethics review?

Answer YES. Provide the application ID for the lead site application.

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