Progress reporting realignment initiative
We have seen significant improvement with compliance since Bellberry began a significant progress reporting realignment initiative. 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-MM 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. 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 reporting key updates:
Each Principal Investigator is responsible for submitting an annual progress report relating to study activities at their site. Responsibility should only be delegated to site staff with appropriate understanding of site-based activities. Reporting opens within 30 days of the due date. Progress reports submitted outside of earlier than this time frame will be returned.
Often sites require submission of amendments and progress reports in a similar timeframe. eProtocol does not allow concurrent submissions of amendments and progress reports. To ensure that continuous ethical approval is maintained, where a progress report is due to be submitted (i.e. within 30 days of the due date) and an amendment is also required (e.g. protocol/IB update), the site must:
- Submit the progress report*.
- Phone or email bellberry@bellberry.com.au to request expedited review of the progress report
- Submit the amendment immediately post progress report acknowledgement.
- When applicable, please phone or email Bellberry to request urgent processing of progress reports preventing an amendment submission.
*When considering whether to attach documents to the progress report, please note that only documents directly relating to the progress report should be included. Any other documents must be submitted by the appropriate pathway (e.g. an amendment, safety, or serious breach form) as these reports are categorised and reviewed according to the extent and impact of any changes. Please see BA F1.1.1 Submission requirements checklist for further information.
If any discrepancies are identified when completing the progress report, the researcher should:
- Note the disparity in the appropriate question field in the progress report before the progress report is submitted.
- Provide the HREC with the relevant documentation through the appropriate pathway immediately post progress report acknowledgement (e.g. submission of an amendment, safety, or serious breach form).
Final reporting key updates:
If a Principal Investigator has finished the study at their site, and the progress report is due, and the closeout visit has not occurred, the site must submit a progress report. Once the closeout visit occurs, any outstanding correspondence identified as requiring submission is to occur by the appropriate channel (e.g. amendment, safety, serious breach) before submitting the final report to the HREC.
If you have any questions or queries regarding these updates, please contact the Quality Team at quality@bellberry.com.au.