eProtocol

2017 Education Session

Bellberry Education Evening’s Professor Ian Frazer AC, Thurs 9 November 2017, Adelaide Cancer Immunotherapy The Gardisil Story Navigating the murky […]

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Contacts

For further information regarding applications please contact: Jerneen Williams, Bellberry HREC EPCT Manager: Contact: 08 8361 3222, Direct Line: 08 […]

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Observer Process

Under the EPCT Framework Senior Executives and/or Research Directors from NSW PHOs that are included as part of an application […]

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Applications

In addition to Bellberry’s submission guidance, each application should include a NSW HREC Fee Form and address the following; Planned […]

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Local procedure for document management. Our internal quality team and some sites are interpreting the statement below to mean that sites need a SOP of some form for their site-specific documentation. This is not always going to be the case, especially with very small private clinics. I don’t know if this is the intention of the statement so I would like to understand from your perspective.

https://bellberry.com.au/ufaqs/master-and-site-specific-picf-and-other-participant-facing-documents/ “Sites are no longer required to submit tracked and clean site-specific PICFs and other site-specific participant facing documentation to […]

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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. […]

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