We have made updates to several documents under Bellberry Applications (BA) and Monitoring of Approved Research (MAR). These changes aim to improve clarity, ensure compliance with current regulations, and enhance the efficiency of our processes. Please review the modified documents to stay informed about the latest updates:
BA F5.1.1 Public Photographic & videographic release content
We have reviewed and updated the document to clarify that consent is required whenever images are identifiable, not just when they are being published. We’ve expanded the consent statements and rewritten that section for clarity.
(I, the undersigned)
Understand that once any of the image(s) referred to above have been published, the researchers have no control over subsequent use and disclosure of the images; the images will be in the public domain, and it will not be possible to revoke consent.
Understand that I can withdraw permission for the further use of my image(s) at any time.
BA G9 Advertising and social media
We have updated the document to improve wording and provide further clarity, without changing our position. Since this update focuses on wording and clarity, we encourage users to read the document in its entirety instead of relying on small excerpts.
Advertising: We now include detailed explanations of the difference between generic and study-specific advertising and guidelines on which types require HREC review. We’ve also added practical examples to help sites make these determinations.
Media Coverage: We have added a new section to guide sites on when HREC review is necessary for media coverage and what should be included in a submission.
Overall Improvements: We have revised the document to eliminate redundant information and reorganised it for greater clarity.
BA G12 Version control and document naming conventions
Previously, BA G12 did not address the practice of distinguishing between Clean and Track change documents. The update to the guidance has introduced a standard notation system—using CL for Clean documents and TK/TC for Track Change documents—which could provide significant benefits:
- Clarity: Immediately identifies the type of document, reducing confusion.
- Version Control: Helps in tracking revisions and updates accurately.
- Efficiency: Facilitates quicker reviews and approvals by clearly showing changes.
While we recognise that version control practices are site-specific and not mandatory, incorporating this notation into our guidance could be particularly valuable for new research sites. It encourages best practices in documentation and version control.
All Updated Documents: File names for updated documents should include:
- Standard naming conventions with the addition of either ‘Clean’ or ‘Tracked’. Abbreviations are acceptable (e.g., CL, TK/TC).
- Bellberry preferred file name:
- Multi-Centre: VRP1001 BB Master Main PICF V1.0_30Mar2020_Clean
- Multi-Centre: VRP1001 BB Master Main PICF V1.0_30Mar2020_Tracked
MAR G4 Progress and Final reports
Administrative close out of expired applications
The following wording has been added to MAR G4:
Bellberry will administratively close applications for studies where ethical approval has expired for more than 45 days. If you do not submit a progress report or final report within 45 days of expiration, Bellberry will process a final report to close out the application administratively.
The following wording will be on the final report letter:
Bellberry has closed this application for administrative purposes following its expiration. If this study is ongoing at your site, you will need to submit a new application. Please contact Bellberry for assistance.
Please note:
- The administrative closure will occur after the Principal Investigator (PI) and nominated contacts receive automated warnings from eProtocol 30, 14, and 7 days before the expiration date (which is also the progress report due date), followed by an email from Bellberry administration two days before expiry.
- If we do not receive the progress or final report within 30 days of the expiration date, we will inform the PI and nominated contact that we will administratively close the study 45 days after expiry.
- After the 45-day closure, Bellberry administration cannot reactivate the study. If the study is ongoing at your site, you must submit a new application, and new application fees may apply (please refer to BA G6 Application Fees).