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) applications that will be conducted at  NSW Public Health Organisation institutions.

For the purposes of the EPCT Framework ‘Early Phase’ is defined as studies up to but not including Phase II, or studies with a Phase I component. The NSW EPCT quick reference guide provides further guidance. At this time NSW Health has excluded adult EPCT from the National Mutual Acceptance (NMA) scheme, meaning NSW public health institutions cannot accept interstate HREC reviews for Adult EPCTs

EPCT applications should be submitted via the Research Ethics Governance Information System (REGIS),  however, if a submission has been reviewed by Bellberry previously on behalf of a private institution, the addition of a NSW public institution may also be submitted via eProtocol. Please contact our team to discuss multicentre applications where there are both private and NSW public health institutions. Please refer to the Multicentre Application guidance below.

Please refer to the Bellberry submission guidance for information on the submission processes and requirements, with applications made via REGIS to include the NSW HREC Fee Form. Please note application attachments should reflect the document file name exactly how they should appear on the decision outcome letter.

We encourage you to reach out to the Bellberry team if you require assistance with your research application.

Multicentre Applications

Multicentre EPCT applications, whether including NSW public health institutions or public-private multi-centre submissions, can be reviewed by Bellberry under NSW Early Phase Clinical Trials (EPCT) Framework, with applications made via the following submission pathways;

  • Where the lead submission is from a NSW public health institution, 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. Please also note that ACT public health institutions can now submit an application via REGIS to be included under a Bellberry review for research that meets the NSW EPCT Framework.
  • Where the lead submission is from a private institution, whose application has been received via eProtocol, an application for the addition of a NSW public health site(s) may also be made via the eProtocol platform. Please note that Bellberry requires an application from each multi-centre site as part of a multicentre review made via eProtocol.

Please refer to the Bellberry Guidance BA G1 regarding the submission of Multi-Centre applications, and BA G2 eProtocol navigation guide for researchers for guidance regarding registering and creating an application in eProtocol.

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

Investigator Initiated Research

A subsidized HREC review fee is available to investigator funded EPCT applications submitted to Bellberry for NSW public health institutions. Please contact the Bellberry team to discuss this prior to submission.

Observer Process

Senior Executives and/or Research Directors from NSW public health institutions that are listed on an NSW EPCT HREC application will be invited to attend the HREC review of that specific EPCT HREC meeting as an ObserverObservers can nominate to attend in person or remotely.

For further information regarding applications please contact:

Jerneen Williams, the Bellberry HREC EPCT Manager:
Direct Line: (08) 81224575
Email: JerneenWilliams@bellberry.com.au

Maria Calarco, the Bellberry HREC EPCT Officer:
Direct Line: (08) 81224665
Email: MariaCalarco@bellberry.com.au

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