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 the lead site has yet to be approved please submit your site application via eProtocol, however you do not need to attach any study documentation on page 7 of your application. If your lead site has already received HREC approval you will need to submit a full application including all your site’s study documentation on page 7”
In this context, we define ‘full application’ to mean each site must complete an application in eProtocol and answer all questions. We don’t wish for the definition of ‘full application’ to relate to the uploading of core study documents such as the protocol, IB etc.
The additional sites are only responsible for uploading documents relating to them. The sort of items we would expect to see uploaded:
- CV if not current within 12 months.
- A site-specific form – if applicable.
- Any other site-specific documentation that is not relevant to other sites – e.g. social media plan or local advertising.