eProtocol

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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Sponsor submissions

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

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HREC Indemnities

Bellberry accepts both electronic and hard copy HREC Only indemnities. If an indemnity is to be sent via an electronic […]

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Progress reports

Minor changes have been made to the progress report form to incorporate the need for submissions to include an update […]

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