Category: <span>Blog</span>

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.

Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study documents. Additional sites will not need to submit any study documentation that has been submitted by the first submitting/lead site, irrespective of when the additional site joins. However, additional sites are responsible for submitting documents that have not been submitted by the first submitting/lead site (e.g. documents pertaining to the additional site: CV, social media plan, advertising, etc.). Please refer to BA F1.1.1 Submission requirements for further information.

Additional site submissions will be considered by the Chair/reviewers as the first submitting/lead site enters cycle comments, post-HREC review.  When the first submitting/ lead site is ready for approval, any additional sites that have fulfilled the HREC’s requirements will be included on the first submitting/lead site approval letter.

When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.

Please refer to BA F1.1.7 HREC process flowchart for further information.

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.

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.

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).

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.

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

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.

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.

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

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.

Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study documents. Additional sites will not need to submit any study documentation that has been submitted by the first submitting/lead site, irrespective of when the additional site joins. However, additional sites are responsible for submitting documents that have not been submitted by the first submitting/lead site (e.g. documents pertaining to the additional site: CV, social media plan, advertising, etc.). Please refer to BA F1.1.1 Submission requirements for further information.

Additional site submissions will be considered by the Chair/reviewers as the first submitting/lead site enters cycle comments, post-HREC review.  When the first submitting/ lead site is ready for approval, any additional sites that have fulfilled the HREC’s requirements will be included on the first submitting/lead site approval letter.

When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to eProtocol page 7 of the additional site’s application. The additional site is responsible for checking that the approved documents match the documents on file. If the site has any documents that do not match those approved (e.g. they have a more recent version of the protocol), the site is responsible for contacting the sponsor to determine which of the approved sites will be responsible for submitting an amendment.

Please refer to BA F1.1.7 HREC process flowchart for further information.

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.

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.

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).

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.

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

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.

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.

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