Bubble Amendments Back to 'Bubble trial' Substantial Amendments The links below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents. Amendment 3.0 MHRA Approval letter [.pdf] REC Approval letter [.pdf] Amendment 2.0 Approval letter [.pdf] Amendment 1.0 Approval letter [.pdf] REC Cover letter [.pdf] Protcol v2.0 [.pdf] PIS v2.0 [.pdf] Non-Substantial Amendments As yet there have been no non-substantial amendments to the Bubble Trial