Archives: <span>FAQs</span>

1. Does not need to be listed in site-specific clauses document as the wording has been ethically approved in the Master PICF, so site deleting the not applicable section would be a known admin change.
2. Copy and paste the deleted wording into the site-specific clauses template stating that it is not applicable and therefore deleted.

The correct answer is option 1.

Great suggestion – the change has been made and the document has been republished on our website.

No, the site does not reference the version and date. The site only needs to reference which document their wording is going into (e.g. Master Main, Master Pregnancy).

If the lead has chosen pathway two, and each site has submitted a site-specific clauses document, if they never wish to change any ethical content in their site-specific PICF, we will never receive an update to that document for the rest of the study.

The clauses document is approved, and each time the Master is updated, they include their approved clauses in their site-specific version, which is approved via whatever mechanism they choose for their own site (e.g. Clin Trial Manager go-ahead, CRO sign off etc).

Yes, if the lead selects pathway 2.

It is for the following reasons:

• The sites are submitting it to confirm they aren’t making changes.
• If there are ethical changes, then the RGO/other institutional representative has a point of reference that the HREC has reviewed the wording, and it is OK for inclusion. We hope that it can help with making the line clear between what is ethics and what is governance. Governance is then about adding administrative items (headers, footers, logos, local site complaints).
• The real value in the document is post-approval. If the site is not changing any site-specific content, they are free to create a site-specific PICF on the same day as the Master is approved. Historically, they may have created it, but they would then need to submit it to the HREC and await approval. In discussion with sites, we found our former approach caused issues when a Master PICF had urgent safety updates, and sites were then waiting for their site-specific PICFs to be approved post Master.

When we audit a study, if we find ethical changes to the site-specific PICF that were not submitted in the site-specific clauses document, we will bring it to the PI’s attention. We recognise there is no clauses document for historical studies, so we would go by the previously approved site-specific PICF.

The Committee will want to see the radiation report (if above standard of care) and the wording from that report placed in the site-specific wording doc. The HREC notes the radiation report, whereas they approve the site-specific wording.

If the lead has already imbedded the radiation report wording of multiple sites into the Master PICF, then it would not need to be put in the site-specific doc.

Insurance and indemnities
Insurance and indemnities FAQ
MA Clinical HREC Indemnity (1 Oct 2012)
MTAA Device HREC Indemnity (10 April 2024)
Bellberry non-clinical HREC indemnity

New applications: The first submitting/lead site must consult BA F1.1.17 PICF submission pathways to determine how the master study documentation will be submitted. There are now three submission pathways:

• Option 1 for single centre submission;
• Option 2 is a flexible submission pathway (which is the same as currently in place);
• Option 3 for where the initial submitting/lead site takes submission responsibility.

A question has been added to the application form asking the Principal Investigator to confirm which PICF pathway has been chosen for the submission. Only one pathway may be selected per study for review by a Bellberry HREC. Each additional site will need to align with the study’s nominated pathway, chosen by the first submitting/lead site.

Sites are no longer required to submit tracked and clean site-specific PICFs and other site-specific participant facing documentation to Bellberry. This change allows sites with research governance offices (or other formal institutional arrangements for reviewing site-specific documentation) to go ahead without the need for further HREC review. Sites that do not have a formal institutional arrangement will be responsible for developing a local procedure for document management.

The PICF submission pathway will determine what documentation is required from each site. Major site-based changes (e.g. radiation, pregnancy, reimbursement) to the PICF/participant facing documentation may be written in the master document as placeholders, or by the completion of BA F1.1.12 Site-specific clauses. The content will be reviewed by the HREC in the format determined by the PICF pathway. Minor administrative changes will be the responsibility of the site and do not need to be submitted to Bellberry. These include adding the site name, Principal Investigator details, amending footers, formatting, and other typographical errors.

For current/ongoing studies: Most studies will already be consistent with one of the PICF pathways. If a site has submitted a site-specific PICF/document to Bellberry, the HREC will have already approved the site-specific content and listed it on an approval letter. If the master document is updated, the site can continue to imbed previously approved clauses into the new site-specific PICF/document without the need for further HREC review. If the site wishes to change a clause, the site must submit an amendment using the BA F1.1.12 Site-specific clauses template.

Sponsor representatives are able to help build the applications in eProtocol. See registration requirements under BA G1 Submission requirements and responsibilities

As a reminder, earlier this year, Bellberry removed the requirement to submit the following documents for which the institution is responsible:

• Insurance certificates
• Standard indemnities
• Site approval forms*
• Protocol signature pages
• Professional indemnities

These are still required to be in place, and available at the site.

*Site approval forms, in this context, refer to the procedure of form put in place by the Institution or Organisation conducting the research. The Bellberry site approval form has been retired.

A list of submission requirements is available under Bellberry Applications BA F1.1.1 Submission requirements checklist.

Changes to the administration and approval processes will be monitored through the Bellberry site monitoring programme, in order to assess the compliance with the outlined process changes.  A review of the implementation of these changes will be undertaken to ensure overall suitability.

Bellberry routinely monitors sites and studies. Sites selected for monitoring may be for cause or chosen at random. In 2020, Bellberry has added desktop auditing to the annual monitoring calendar.  (Through 2020 it is anticipated that all monitoring will be undertaken via remote methods, with a return to physical site monitoring when safe to do so.)

From 2021, the changes to administration of additional sites will form part of the monitoring agenda. If your site or study is selected for monitoring (either by desktop or site visit methods), the Bellberry quality team will email all relevant forms for completion to the Principal Investigator and nominated contacts.

Bellberry accepts both electronic and hard copy HREC Only indemnities. If an indemnity is to be sent via an electronic platform such as DocuSign or AdobeSign, please do not complete any fields for the Bellberry signatory.

Please send any electronic HREC Only Indemnities to bellberry@bellberry.com.au. If your processes require it to be sent to an individual, please also copy to bellberry@bellberry.com.au.

Bellberry does not require the submission of Standard Indemnities. Researchers and Sponsors can find information on Bellberry’s requirements for HREC Only Indemnities in BA G15 Insurance and indemnities

For clarity, Bellberry requests files to contain the title, version and date of the document. Please refer to BA G12 Version control and document naming conventions for further information.

Minor changes have been made to the progress report form to incorporate the need for submissions to include an update on any conflict of interest changes for the research team, and for a comment on compliance with any: governance approvals; submission of amendments; safety reporting; annual progress reporting; notification to the HREC of regulatory audits; appropriate use of data; caveats placed on the approval; statutory and licensing obligations. See MAR F4.1.1 Progress reports (eProtocol questions).

Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to reflect the NHRMC’s serious breach questions. Sites may complete these questions, or upload MAR F3.1.1 Serious breaches report form – sponsor or MAR F3.1.2 Serious breaches report form – third party, as applicable.

Please note, the acknowledgement letter will code the item as ‘PVR’; this is system-generated and cannot be altered.

If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master PICF or investigator brochure, DSUR, ASR), the submission will be reviewed on behalf of all Bellberry approved sites. In the event the submission does not apply to all of these sites, the submitting site must provide an explanation. Please refer to MAR F1.1.3 amendment pathways flowchart for further information.