FAQ Category: Submission changes 2020

Yes, if the lead selects pathway 2. It is for the following reasons: The sites are submitting it to confirm […]

New applications: The first submitting/lead site must consult BA F1.1.17 PICF submission pathways to determine how the master study documentation […]

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

As a reminder, earlier this year, Bellberry removed the requirement to submit the following documents for which the institution is […]

Changes to the administration and approval processes will be monitored through the Bellberry site monitoring programme, in order to assess […]

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

For clarity, Bellberry requests files to contain the title, version and date of the document. Please refer to BA G12 […]

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

Protocol deviations and violations do not need to be reported to Bellberry HREC. The PVR form has been updated to […]

If an amendment or safety report in a multi-centre study relates to core study documentation (such as the protocol, master […]

When an additional site is approved after the initial study’s approval, Bellberry administration will upload all previous approval letters to […]

Each site is responsible for submitting an initial application. The first submitting/lead site is responsible for submitting all core study […]