eProtocol

Milestone Submissions

Bellberry Limited
A

Milestone Submissions

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:

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

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 EPCT@bellberry.com.au.

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 some but not all sites in the REGIS application are closing out:
    • 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/

Go back