Archives: <span>FAQs</span>

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.

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.

From the ‘investigator’ home page, Principal Investigators will be able to view a complete list of submissions for projects under their responsibility. Applications will be grouped into ‘applications (in preparation/ submitted), ‘approved applications’, or ‘non-active applications’.

From the ‘investigator’ home page, holding Ctrl+F will display a search bar. Entering an identifier such as the HREC application ID into the search bar will highlight items on the page that match the search criteria.

From time to time a submission may not be visible from the ‘investigator’ home page. This may occur when a new Principal Investigator has taken over responsibility for a project, or when a Co-Investigator/ nominated contact completes a submission on behalf of an investigator.

To access a submission that is not visible on the eProtocol landing page:

Hover over the eProtocol tab in the top left-hand corner of the page
Move the mouse to hover over ‘investigator’. A list of options will Click ‘search protocol’.
Enter the relevant HREC application ID the search box. Click ‘search’.

If uncertain of the specific HREC application ID, type a different identifier into one of the search fields. For example, entering the Principal Investigator’s name into the search box and clicking ‘search’ will display a complete list of all submissions made by, or on behalf of, that investigator. Alternatively, selecting the organisation name and clicking ‘search’ will display a complete list of all submissions for projects occurring at that site.

A combination of search fields may be used, such as: