eProtocol

NSW PHO EPCT

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 (PHO) sites.

For the purposes of this Framework ‘Early Phase’ has been broadly defined as studies up to, but not including, Phase II studies. The NSW EPCT quick reference guide provides further guidance.

NSW PHO EPCT applications should be submitted via the Research Ethics Governance Information System (REGIS). Please upload documents with the file name exactly how you would like it to be recorded on the approval letter.

NSW EPCT Bellberry Application Guidance

We encourage you to reach out to the Bellberry team at any time for assistance with your research application. Our website has additional resources and guidance regarding Protocol and Participant Information and Consent Sheet requirements,and useful resources to assist with the EPCT submission process.

The following links are useful resources to assist with the EPCT submission process:

 Multicentre applications and NMA

At this time NSW Health has excluded adult EPCT from the National Mutual Acceptance (NMA) model, meaning NSW PHO sites cannot accept interstate HREC reviews for Adult EPCTs. Bellberry does, however, review multicentre applications, and you can call or email to discuss multicentre applications where there are both private and NSW PHO sites.

Investigator Initiated Research

As with all applications, please contact us at any time if you require assistance with your application or study documents. A subsidized HREC review fee is available to investigator funded research. Please contact the Bellberry team to discuss this prior to submission.

Observer Process

Senior Executives from NSW PHO sites that are listed on an NSW EPCT HREC application will be invited to attend the review of that specific EPCT HREC meeting as an Observer. Observers can nominate to attend in person or remotely.

For further information regarding applications please contact the Bellberry HREC EPCT Manager:

Jerneen Williams, Early Phase Clinical Trial Manager

Phone: (08) 8361 3222

Direct Line: (08) 81224575

Email: JerneenWilliams@bellberry.com.au