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, an application for a NSW 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.