Multi-centre 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 multi-centre 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.