CALiBRe Amendments Back to 'calibre' Summary of Amendments [.pdf] Above is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders 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. Substantial Amendment 4 The files below are the relevant amended documents and approval letters for Substantial Amendment 4. CALiBRe SA04 REC approval_17-Feb-2017 [.pdf] CALiBRe SA04 HRA approval_13-Mar-2017 [.pdf] CALiBRe SA04 MHRA approval_06-Mar-2017 [.pdf] CALiBRe SA04 MHRA cover letter_01-Feb-2017 [.pdf] CALiBRe SA04 REC cover letter_01-Feb-2017 [.pdf] CALiBRe SA04 Notice of Substantial Amendment_01-Feb-2017 [.pdf] CALiBRe SA04 MHRA products form_01-Feb-2017 [.pdf] CALiBRe Participant Information Sheet and Consent Form v2.0_05-Dec-2016 [.docx] CALiBRe Participant Information Sheet and Consent Form v2.0_05-Dec-2016_tracked changes from V1.0a [.docx] CALiBRe_GP_Letter_vn2.0 03-Dec-2016 [.docx] CALiBRe_GP_Letter_vn2.0 03-Dec-2016_tracked changes from v1.0 [.docx] CALiBRe_GS_1101_Protocol_Version 2.0_08-Dec-2016_clean [.pdf] CALiBRe_GS_1101_Protocol_Version 2.0_08-Dec-2016_tracked changes from v1.0b [.docx] PI protocol signature page [.docx] Substantial Amendments 1-3 The folders below contain the relevant amended documentation and approval letters for Substantial Amendments 1 to 3. Amendment 3.0_14-Mar-2016 - not needed by Sites Amendment 2.0_10-Apr-2015 [.zip] Amendment 1.0_11-Feb-2015 [.zip] Non-Substantial Amendments NSA02_05-Oct-2015 [.pdf] Patient Diary v1.0a [.pdf] NSA01_06-Aug-2015 [.pdf] Protocol v1.0b [.pdf]