Progress reporting realignment initiative
During 2021 Bellberry implemented a new approach to annual reporting, making use of technology solutions to improve performance. The primary objectives of the project were to:
- Support researchers maintain compliance with the terms and conditions of ethical approval and obligations under the National Statement on Ethical Conduct in Human Research.
- Move all studies to a one-year term of approval, allowing system-generated alerts to be issued when progress reporting is due.
- Align progress reporting dates for all sites participating in the same research project. The DD-MMM cycle of the initial submitting site will determine the due date for all supplementary sites.
- Ensure Bellberry meet accreditation and certification obligations under AAHRPP (Association for the Accreditation of Human Research Protection Programs) and NHMRC (National Health and Medical Research Council).
Progress and final reporting: guidance materials
Bellberry provides the following documents relating to progress and final reporting:
MAR G4 Progress and final reports
This guidance outlines researcher and sponsor obligations concerning progress and final reports as per clause 5.5.5 of the National Statement on Ethical Conduct in Human Research (2007 incorporating all updates).
MAR F4.1.1 Progress report (eProtocol questions) and MAR F4.1.2 Final report (eProtocol questions)
These forms provide a comprehensive list of questions asked via the eProtocol progress and final report form. These forms have been updated to include what researchers should consider when preparing responses to progress and final report questions. These forms also outline which responses are not acceptable and that the HREC will return reports with unacceptable responses. Researchers may use these forms to prepare responses before submission to eProtocol.
BA F2.1.12 Creating a progress report and BA F2.1.13 Creating a final report
These forms provide technical guidance to assist users unfamiliar with eProtocol to submit progress or final reports via the submission platform.
Progress and final reporting: Email correspondence
Most email correspondence regarding progress and final reports will be sent to you from quality@bellberry.com.au. To ensure that these emails are received (and not moved to a junk/spam folder), please add quality@bellberry.com.au to your list of email contacts.
Progress reporting key information:
Please submit a progress report before an amendment if you are within the 30-day reporting period:
- If there are no issues with the progress report, it should not delay your ability to submit an amendment by more than 24 hours.
Auto alert expiry reminder emails:
- Be prepared to complete your progress report when you receive the first auto alert reminder email from eProtocol (emailed 30, 14 and 7 days before expiry).
- Bellberry administration will email sites that have not submitted a progress report/ethics approval extension request within the final days in an attempt to ensure they do not expire and run the risk of continuing to run their research without ethical approval.
The progress report/ethics approval extension may not be available for the following reasons:
- You have an amendment or final report ‘In Preparation’ or ‘Submitted.’ These submissions will need to be deleted before the progress report/ethics approval extension option will be available.
- You are more than 30 days in advance of the application’s expiry date.
- If none of the above reasons apply and you are still unable to see the progress report/ethics approval extension option, please email quality@bellberry.com.au with the Application ID/PI name in the subject line and a short message informing the team that you do not have an option to select a progress report/ethics approval extension.
Which pages can be updated:
- Please only edit the Progress Report/Ethics Approval Extension page and page 7 of the Application Information page (the attachments page).
What kind of documents can be attached?
- When considering whether to attach documents to the progress report, please note that only documents directly relating to the progress report should be included. Please see BA F1.1.1 Submission requirements checklist for further information.
- Any new safety information (such as a DSUR) should be provided to the HREC via an adverse event/safety report submission after completing the progress report.
- Any updated study information (such as a protocol, PICF or IB update) must be provided to the HREC by way of an amendment following completion of this progress report.
Conflict of interest question (“Provide an update on any conflict of interest changes for the research team in the last 12 months. The changes may be actual, perceived or potential, as per National Statement 5.2.11 or 5.4.”):
- If an actual, perceived, or potential conflict of interest has been declared in your response to this question, please do not update page 6 of the Application Information page with this information yet.
- A note may be included on the progress report approval letter if an amendment submission is required to update page 6 of the Application Information page and what date the amendment submission is due by.
- The amendment submission is required for auditing purposes so that there is a clear record of an amendment to the application which is why the update to page 6 of the Application Information page should not be made on the progress report.
‘Progress Report’ and ‘Ethics Approval Extension’ radio buttons:
- The ‘Ethics Approval Extension’ request radio button should be selected, and the ‘Current Study Close Date’ and ‘New Study Close Date’ filled in.
- However, if a progress report is received with the ‘Progress Report’ radio button selected, Bellberry will edit the form to select the ‘Ethics Approval Extension’ radio button, will enter the correct extension dates and will enter a note on the progress report form to advise that Bellberry has edited the extension dates on the form.
Final reporting key information:
A submission of the final report can only occur after all study activity at a site has finished, including the submission of amendments, protocol violation or serious breach reports, safety reports, and any other correspondence. This generally occurs after the close-out visit (clinical trials) or final reconciliation of study activities (non-clinical trials).
If a Principal Investigator has finished the study at their site, and the progress report is due, and the close-out visit has not occurred, the site must submit a progress report first to ensure that ethical approval does not lapse.