Please only submit electronic indemnities listing sites that have applied or are due to apply in the coming days. Bellberry […]
Learn more...If the lead site was approved before the submission changes, do they need to submit anything when a new site is added?
The lead site only needs to choose a pathway. There may be some situations where updated documentation is required, but […]
Learn more...My site is ready to submit in 2021, but the lead site and other additional sites were approved in August 2020. No other sites have been added since Bellberry updated its submission process. How do I know what pathway I should follow?
Please contact the Sponsor and get them to confirm with the site that submitted the initial application (lead) which pathway […]
Learn more...The lead site at the initial submission has chosen pathway 2. One of the additional sites submits a protocol amendment during the study and their documentation is aligned with pathway 3. They have now re-aligned the PICF pathway. Is that possible?
The HREC administration keeps a record of the lead site’s PICF pathway at the initial submission. If a site tries […]
Learn more...Can you please clarify if the statement “submit a full application” is still correct under this new process? I thought only the submitting site (which is no longer limited to the lead site) has to submit the full application and now BB will be helping link additional sites to that full application.
The BB website lists the FAQ below: “If I have an additional site what do I need to submit and […]
Learn more...Another scenario: There are 4 sites as part of a multi-centre study, and the lead site has chosen PICF pathway 2 and submitted the Master PICF + their site-specific clauses. All other sites have submitted their site-specific clauses prior to EC approval. EC has queries about Site 2 and Site 3’s site specific clauses document. Does this hold up the initial EC approval letter for the Lead Site and Site 4?
No. It only holds up the site/s in question. Suppose it is something minor that could be dealt with swiftly. […]
Learn more...Our Master PICFs can have optional wording in the body of the PICFs so sites can select the relevant statement for their site and delete the other e.g. 2 radiation statements. Which of the 2 options below is correct?
Does not need to be listed in site-specific clauses document as the wording has been ethically approved in the Master […]
Learn more...The naming convention for the site-specific clauses document is not listed in BA G12. Can this be added? Our suggestion is that it should be “Protocol Number_MyHospitalAcronym_Site Specific Clauses_Version#_DD/MMM/YYYY”
Great suggestion – the change has been made and the document has been republished on our website.
Learn more...Does the Master PICF version & date have to be referenced in the site-specific clauses document? This won’t be possible if the site-specific clauses document is submitted at the same time as the draft Bellberry Master PICF.
No, the site does not reference the version and date. The site only needs to reference which document their wording […]
Learn more...Typically, we get sites to submit a radiation report from their local physicists that will contain their site-specific radiation wording for the PICF. Under the new set up, does Bellberry want the actual radiation report to still be submitted, or can sites just use the Site-Specific Clauses form for their site-specific radiation wording?
03/03/2021
The Committee will want to see the radiation report (if above standard of care) and the wording from that report […]
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