NSW Early Phase Clinical Trial Framework

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

In addition to Bellberry’s submission guidance, please review and include the information in the REGIS application checklist or include the completed checklist with your application.

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.

Annual/Progress Milestone Reports
A site-specific MAR F4.1.1 Progress Report form must be completed by each site and included in the Milestone Annual/Progress Report submission in REGIS.

Lead Site in REGIS:

• Request each site included in the REGIS application to complete and provide the MAR F4.1.1 Progress Report. If there are any issues, the site/s can email the form to the EPCT team at [email protected].
• Complete the Annual/Progress Report in REGIS and upload the MAR F4.1.1 Progress Report forms for all sites.

Multi-centre site in REGIS with lead site in REGIS:

• Complete the MAR F4.1.1 Progress Report form for your site and provide it to the site that will be submitting the milestone in REGIS. If there are any issues, the form can be emailed to the EPCT team at [email protected].

Multi-centre site in REGIS with lead site in eProtocol:

• Where the lead site is in eProtocol rather than REGIS the lead site in eProtocol will only submit their own site-specific Final Report in eProtocol.
• One of the sites in the REGIS application will need to be the submitting site and submit the report on behalf of themselves and any other REGIS sites following the instructions above.

Ethics approval expiry
Ethics approval will expire on the day of the approval end date. The Annual/Progress Report in REGIS should be submitted with the MAR F4.1.1 Progress Report form prior to the ethics approval expiry date to allow time for review and approval.

If there are any issues with submitting the Annual/Progress report in REGIS prior to the ethics expiry date, please contact the EPCT team at [email protected].

If ethics approval expires, researchers must ensure:

• All research activities stop.
• New enrolment of participants does not occur.
• If the site has participant visits scheduled, the HREC will decide if it is in the best interests of individual participants to continue participating due to an over-riding safety concern or ethical issue.
• The site must outline what participant visits and other study-related conduct have occurred in the period between the report being due and the submission of the notification.

Final Milestone Reports
In addition to the REGIS Milestone Final Report submission, a site-specific MAR F4.1.2 Final Report form must be completed by each closing site and included in the submission.

Lead site in REGIS:

• Where all sites in the REGIS application are closing out:
  • All sites will need to complete the MAR F4.1.2 Final Report form and provide to the submitting site, if there are any issues the report can be sent via email to the EPCT team at [email protected]
  • The submitting site will need to submit the Milestone Final Report in REGIS and upload the MAR F4.1.2 Final Report for each site.

• Where some but not all sites in the REGIS application are closing out:
  • The closing site/s will need to complete the MAR F4.1.2 Final Report form and provide to the submitting site, if there are any issues the report can be sent via email to the EPCT team at [email protected]

• • The submitting site will need to submit a General Amendment notifying the HREC of the closing sites and upload the MAR F4.1.2 Final Report forms for each closing site.

Lead site in eProtocol:

• Where the lead site is in eProtocol rather than REGIS the lead site will only submit their own site-specific Final Report in eProtocol.
  • One of the sites in the REGIS application will need to be the submitting site and submit the Milestone Final Report on behalf of all closing REGIS sites following the instructions above.

Guidance
Please see the below link to the Bellberry progress and final report guidance document:
MAR G4 Progress and Final Reports

For information on how to submit a Milestone in REGIS, refer to the below QRG:
Submitting Annual Progress or Final Report (Milestone)

For further REGIS guidance, please refer to the following link to the Quick Reference Guide web page: https://regis.health.nsw.gov.au/how-to/

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 Director of Operations:
Contact: 08 8361 3222, Direct Line: 08 81224575
Email: [email protected]

Sally Gordon, Bellberry Research Manager:
Contact: 08 8361 3222
Email: [email protected]

Maria Calarco, Bellberry HREC EPCT Officer:
Contact: 08 8361 3222, Direct Line: 08 81224665
Email: [email protected]

Ali Young, Bellberry HREC EPCT Officer:
Contact: 08 8361 3222, Direct Line: 08 81224582
Email: [email protected]

For general enquiries please email: [email protected]